Terms of use

4.1.1. Rayvolve - K260378

Indications for use

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures, joint effusions and dislocations during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for the adult and pediatric population (≥2 years).

Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types.

Rayvolve is indicated for use in adult and pediatric populations to help detect fracture, dislocations and joint effusions on osteoarticular X-rays of the following anatomic area of interest/radiographic views:

Study type (Anatomic Area of interest) / Radiographic Views* supported for fracture detection:

• Ankle / AP, Lateral, Oblique
• Clavicle / AP, AP Angulated View
• Elbow / AP, Lateral
• Forearm / AP, Lateral
• Hip / AP, Frog leg lateral
• Humerus / AP, Lateral
• Knee / AP, Lateral
• Pelvis / AP
• Shoulder / AP, Lateral, Axillary
• Tibia/fibula / AP, Lateral
• Wrist / PA, Lateral, Oblique
• Hand / PA, Lateral, Oblique
• Foot / AP, Lateral, Oblique.
• Ribs AP
• Spine PA, Lateral

Study type (Anatomic Area of interest) / Radiographic Views* supported for dislocation detection:

• Shoulder / AP, Lateral, Axillary
• Elbow / AP, Lateral
• Hand / PA, Lateral, Oblique

Study type (Anatomic Area of interest) / Radiographic Views* supported for joint effusion detection:

• Elbow / AP, Lateral
• Forearm / AP, Lateral
• Arm / AP, Lateral

*Definitions of anatomic area of interest and radiographic views are consistent with the ACR-SPR-SSR Practice Parameter for the Performance of Radiography of the Extremities guideline.

Undesirable side effects

No adverse side effects related to the use of Rayvolve have been reported.

Warnings

• The users may use Rayvolve only for the intended anatomical regions indicated in this operating manual. Rayvolve is not intended to detect abnormalities from anatomical areas of interest outside the indication for use, the users should review original images for all other suspected pathologies and other anatomical regions and shall rely on their own diagnostic if ever Rayvolve detects abnormalities from anatomical areas outside the indication for use. If Rayvolve encounters an image or an exam outside of the anatomical areas in the instruction for use, it will not be processed by Rayvolve and no Secondary Capture will be generated by Rayvolve. Be careful when you fill in the study description of the exam you perform that the anatomic area of interest is well completed and in the indication for use of the configuration of Rayvolve that you use.
• The same bounding zone can contain several adjacent pathologies: the users shall proceed to a concurrent read with the original X-ray.
• It is possible that a bounding zone hides a part of an adjacent pathology; the users shall proceed to a concurrent read with the original X-ray.
• Rayvolve is not intended to detect pathologies in other modalities than X-rays.
• Poor image quality can affect Rayvolve's detection of pathologies: the users shall proceed to a concurrent read with the original X-ray.
• In the event of a significant change in Rayvolve's performance, please contact AZmed.
• Rayvolve is a diagnostic aid, only the users' diagnosis remains valid for the patient.
• Any serious incident occurring in connection with the device should be notified to AZmed and to the competent authority.
• Some fractures specific to children are not found in adults and may be more difficult to identify. Always use Rayvolve with caution when using it in children.
• Rayvolve analyses images for fracture per view; multiple views may be needed per ACR guidelines.
• The following views are primarily intended for the pediatric population: oblique hand and foot, AP angulated clavicle, and lateral pelvis.
• The images provided by Rayvolve are AI-aided automated analysis only. It shall not replace a physician's diagnosis. A disclaimer is displayed on the duplicate and the report generated by Rayvolve.

Contraindication and precautions

• Do not use Rayvolve to detect foreign matters.
• If Rayvolve encounters an image or an exam outside of the anatomic areas of the indication for use, it will not be processed by Rayvolve and no Secondary Capture image will be generated by Rayvolve.
• If Rayvolve encounters an exam inside of the anatomic areas of the indication for use, but the exam contains a part or an entire fracture outside of the anatomic areas in the indications for use (for instance a rib fracture present in a shoulder exam), Rayvolve will process the image. If Rayvolve processes the exam the user should not consider the analysis of Rayvolve regarding the part of the image outside of the anatomic areas in the indication for use.

Notes

• No unacceptable residual risks were identified for Rayvolve.
• This product integrates artificial intelligence (AI) technology to support medical image analysis. It does not replace the role of the users: they must not use the output of Rayvolve as primary interpretation.
• In the event of a significant change in Rayvolve's performance, please contact AZmed's support at support@azmed.co
• Rayvolve is not intended to detect abnormalities in other modalities than X-Rays.
• Prior to the deployment of the software, AZmed provides training sessions to healthcare professionals to present the product, explain how to interpret its outputs, and address any questions regarding its use in practice.

Performances claimed

Based on standalone performance testing and on the clinical investigation, we claim that radiologists and emergency physicians:

• Improve their performances in detecting and localizing anomalies on standard radiographs when supported by Rayvolve's prediction
• Reduce their x-rays analysis time

4.1.2. Rayvolve LN - K243831

Indications for use

Rayvolve LN is a computer-aided detection software device to assist radiologists to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30mm size. It is designed to aid radiologists in reviewing the frontal (AP/PA) chest radiographs of patients of 18 years of age or older acquired on digital radiographic systems as a second reader and be used with any DICOM Node server. Rayvolve LN provides adjunctive information only and is not a substitute for the original chest radiographic image.

Undesirable side effects

No adverse side effects related to the use of Rayvolve LN have been reported.

Warnings

• Rayvolve LN is an adjunct tool and does not replace the role of the users: they must not use the output of Rayvolve LN as primary interpretation.
• The users may use Rayvolve LN only for the intended anatomical regions indicated in this operating manual. The users may rely on their own diagnostic if ever Rayvolve LN detects nodules from anatomical areas outside the indication for use.
• The same bounding zone can contain several adjacent nodules: the users shall compare the Secondary Capture image with the original X-ray.
• It is possible that a bounding zone hides a part of an adjacent nodules the users shall compare the Secondary Capture image with the original X-ray.
• Rayvolve LN is not intended to detect nodules from anatomical areas of interest outside the indication for use: user should review original images for all other suspected pathologies and other anatomical regions. If Rayvolve LN encounters an image or an exam outside of the anatomic areas in indications for use, it will not be processed by Rayvolve LN and no Secondary Capture will be generated by Rayvolve LN.
• Poor image quality can affect Rayvolve LN's detection of nodule: the users shall compare the Secondary Capture image with the original X-ray.
• Rayvolve LN is a diagnostic aid, only the users' diagnosis remains valid for the patient.

Contraindication and precautions

• Rayvolve LN is not designed and tested to be used with pediatric patients.
• Do not use Rayvolve LN to detect foreign matters.
• If Rayvolve LN encounters an image or an exam outside of the anatomic areas of the indication for use, it will not be processed by Rayvolve LN and no Secondary Capture image will be generated by Rayvolve LN.
• If Rayvolve LN encounters an exam inside of the anatomic areas of the indication for use, but the exam contains a part or an entire nodule outside of the anatomic areas in the indications for use. Rayvolve LN will process the image. If Rayvolve LN processes the exam the user should not consider the analysis of Rayvolve LN regarding the part of the image outside of the anatomic areas in the indication for use.
• Rayvolve LN is not intended to detect nodules in other modalities that X-rays.
• Any serious incident occurring in connection with the device should be notified to AZmed and to the FDA.
• In the event of a significant change in Rayvolve LN's performance, please contact AZmed's support at support@azmed.co

Notes

• No unacceptable residual risks were identified for Rayvolve LN.
• Rayvolve LN's features have been optimized and tested to minimize prediction errors, some tolerable and acceptable residual risks may still exist concerning false negatives and positives. While false negatives could lead to missed abnormalities, false positives may result in unnecessary follow-up examinations. The predictions provided by Rayvolve LN should always be corroborated by a healthcare professional's judgment to ensure correct interpretation of the results and appropriate patient management.
• In case of trouble with The instructions for use in electronic format, AZmed can provide the instruction for use in paper format at no additional cost for the user in 7 days.

Performances claimed

Based on standalone performance testing and on the clinical investigation, we claim that radiologists:

• Improve their performances in detecting and localizing anomalies on standard radiographs when supported by Rayvolve LN's prediction
• Reduce their x-rays analysis time

4.1.3. Rayvolve PTX-PE - K243808

Indications for use

Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).

Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in the PACS (or other DICOM storage platforms) for worklist prioritization or triage.

As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist.

Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

Undesirable side effects

No adverse side effects related to the use of Rayvolve PTX-PE have been reported.

Warnings

• Rayvolve PTX-PE is an adjunct tool and does not replace the role of the users: they must not use the output of Rayvolve PTX-PE as primary interpretation.
• The users may use Rayvolve PTX-PE only for the intended anatomical regions indicated in this operating manual. Rayvolve PTX-PE is not intended to work on anatomical areas of interest outside the indication for use, the users should review original images for all other suspected pathologies and other anatomical regions and shall rely on their own diagnostic if ever Rayvolve PTX-PE work on anatomical areas outside the indication for use. If Rayvolve PTX-PE encounters an image or an exam outside of the anatomical areas in the instruction for use, it will not be processed by Rayvolve PTX-PE and no Secondary Capture will be generated by Rayvolve PTX-PE. Be careful when you fill in the study description of the exam you perform that the anatomic area of interest is well completed and in the indication for use of the configuration of Rayvolve PTX-PE that you use.
• Rayvolve PTX-PE is not intended to work from anatomical areas of interest outside the indication for use: user should review original images for all other suspected pathologies and other anatomical regions. If Rayvolve PTX-PE encounters an image or an exam outside of the anatomic areas in indications for use, it will not be processed by Rayvolve PTX-PE and no Secondary Capture will be generated by Rayvolve PTX-PE.
• Poor image quality can affect Rayvolve PTX-PE's detection of abnormalities: the users shall proceed to a concurrent read with the original X-ray.
• Rayvolve PTX-PE is a computer-aided triage and notification software, only the users' diagnosis remain valid for the patient and the user remains responsible for the final diagnosis.

Contraindication and precautions

• Do not use Rayvolve PTX-PE to detect foreign matters
• If Rayvolve PTX-PE encounters an image or an exam outside of the anatomic areas of the indication for use, it will not be processed by Rayvolve PTX-PE and no Secondary Capture image will be generated by Rayvolve PTX-PE.
• If Rayvolve PTX-PE encounters an exam inside of the anatomic areas of the indication for use, but the exam contains a part or an entire abnormality outside of the anatomic areas in the indications for use, Rayvolve PTX-PE will process the image. If Rayvolve processes the exam the user should not consider the analysis of Rayvolve regarding the part of the image outside of the anatomic areas in the indication for use.
• Rayvolve PTX-PE is not designed and tested to be used with patients under 18 years old.
• Rayvolve PTX-PE is not intended to work in other modalities than X-rays
• In the event of a significant change in Rayvolve PTX-PE's performance, please contact AZmed.
• Any serious incident occurring in connection with the device should be notified to AZmed and to the competent authority in which the user is established.

Notes

• No unacceptable residual risks were identified for Rayvolve PTX-PE.

Performances claimed

Based on standalone performance testing and on the clinical investigation, we claim that health professionals:

• Improve their performances in prioritization and triage for pre-specified anomalies (pleural effusion and pneumothorax) on standard chest radiographs when supported by Rayvolve PTX-PE's
• Reduce their X-ray analysis time

Rayvolve is indicated for use in adult and pediatric populations to help detect:

• Fractures, dislocations, effusions and bone lesions on osteoarticular X-rays of the following organs: hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, leg, knee, femur, clavicle, hip, humerus, pelvis, tibia, ribs and spine. The vertical handling those functionalities is called AZtrauma
• Abnormalities on chest X-rays such as: consolidation, pleural effusion, pneumothorax, cardiomegaly, acute pulmonary edema, rib fracture, pulmonary nodule, mediastinal widening, lung cavity, lymphadenopathy, interstitial pattern, tuberculosis. The vertical handling those functionalities is called AZchest.
• Bone measures' abnormalities (angle/length) on lower limb (including pelvic, hip, knee, foot) and spine. The vertical handling those functionalities is called AZmeasure.
• Bone characterisation for bone age abnormalities estimation on hand. The vertical handling those functionalities is called AZboneage.

Rayvolve can analyze X-rays of adult and pediatric patients.

The radiographs analyzed are: Computed Radiography (CR), Radio Fluoroscopy (RF) and Digital Radiography (DX)

Undesirable side effects

No adverse side effects related to the use of Rayvolve have been reported.

Warnings

• The users may use Rayvolve only for the intended anatomical regions indicated in this operating manual. Rayvolve is not intended to detect abnormalities from anatomical areas of interest outside the indication for use, the users should review original images for all other suspected pathologies and other anatomical regions and shall rely on their own diagnostic if ever Rayvolve detects abnormalities from anatomical areas outside the indication for use. If Rayvolve encounters an image or an exam outside of the anatomical areas in the instruction for use, it will not be processed by Rayvolve and no Secondary Capture will be generated by Rayvolve. Be careful when you fill in the study description of the exam you perform that the anatomic area of interest is well completed and in the indication for use of the configuration of Rayvolve that you use.
• The same bounding zone can contain several adjacent abnormality: the users shall proceed to a concurrent read with the original X-ray.
• It is possible that a bounding zone hides an adjacent abnormality: the users shall proceed to a concurrent read with the original X-ray.
• Poor image quality can affect Rayvolve's detection of abnormality: the users shall proceed to a concurrent read with the original X-ray.
• Normal ranges of AZmeasure are indicated for adults > 18 years old only.
• The images provided by Rayvolve are AI-aided automated analysis only. It shall not replace a physician's diagnosis. A disclaimer is displayed on the duplicate and the report generated by Rayvolve.
• Some abnormalities specific to children are not found in adults and may be more difficult to identify. Always use Rayvolve with caution when using in children.
• Rayvolve's features have been optimized and tested to minimize prediction errors, some tolerable residual risks may still exist. Rayvolve may present false negatives for pulmonary and cardiological diseases. The predictions provided by Rayvolve should always be corroborated by a healthcare professional's judgment to ensure correct interpretation of the results and appropriate patient management. AZmed does not significantly impact vulnerable persons directly.

Contraindication and precautions

• Do not use Rayvolve to detect foreign matters.
• For chest radiographs, Rayvolve works optimally under optimal conditions: when the patient is facing frontally and in full inspiration.

Limitations

• Rayvolve is not intended to detect abnormalities in other modalities than X-Rays.
• For bone age characterization, if the bone age assessed by Rayvolve is ≥18 years old for a female or ≥19 years old for a male, the bone age will respectfully be indicated by ≥18 or ≥19.
• DICOM Metadata Integrity: Input images must contain accurate and complete DICOM metadata, including but not limited to: modality, body part examined (organ), study description, and patient age. If these data are missing, the image will either be rejected for analysis or processed using an incorrect algorithm, leading to unreliable results.
• The user must utilize a DICOM-compliant viewer to ensure proper image display and interaction.
• For standard Cloud/VM (Virtual Machine) deployments, the client environment must meet the specific technical specifications provided in the technical documentation.
• For Full Cloud variant, the user must ensure a secure remote network connection.
• For On-Premise Deployment, the client must provide the necessary hardware infrastructure or allow for the installation of dedicated hardware.

Notes

• No residual risks were identified for Rayvolve.
• Any serious incident occurring in connection with the device should be notified to AZmed and to the competent authority in which the user is established.
• In the event of a significant change in Rayvolve's performance, please contact AZmed's support at support@azmed.co.
• In case of trouble with the instruction for use in electronic format, AZmed can provide the instruction for use in paper format at no additional cost for the user in 7 days.
• The AI system includes an internal logging mechanism that automatically records key information related to each inference, such as the input image reference, timestamp. While these logs are not directly accessible to the client, they are securely stored and maintained by AZmed. If information related to a specific log event is required (e.g. for investigation, traceability or performance review), clients may contact the technical support team at support@azmed.co.
• This product integrates artificial intelligence (AI) technology to support medical image analysis. If a user requests not to use the AI functionality, the product will be deactivated and removed from the site, as its core features depend entirely on AI-based processing.
• Prior to the deployment of the software, AZmed provides training sessions to healthcare professionals to present the product, explain how to interpret its outputs, and address any questions regarding its use in practice.

Performances claimed

Based on standalone performance testing and on the clinical evaluation, we claim that radiologist and emergency physicians:

• Improve their performances in detecting and localizing abnormalities on standard radiographs when supported by Rayvolve's prediction
• Reduce their x-rays analysis time
• Reduce intra- and inter-observer variability for reproducibility.

Intended purpose / Indications for use

Rayscan AI suite is a computer-aided diagnosis suite of tools, intended to assist trained healthcare professionals in the interpretation of Computed Tomography Scans.

Rayscan AI suite is intended to be divided into verticals, for the moment it only includes AZnod. AZnod is the vertical of Rayscan AI suite designed to assist healthcare professionals in the detection, localization and characterization of pulmonary nodules on Chest CT scans. It provides automated analysis of nodules’ dimensional and morphological characteristics, including volume, size and density, to support lung nodule diagnosis.

Rayscan is indicated for use in adult and pediatric populations to help to detect localize and characterise pulmonary nodules on Chest CT scans.

Undesirable side effects

No adverse side effects related to the use of Rayscan AI suite have been raised.

Warnings

• The images provided by Rayscan AI suite are AI-aided automated analysis only. It shall not replace a physician's diagnosis. A disclaimer is displayed on the duplicate and the report generated by Rayscan AI suite.
• The users may use Rayscan AI suite only for the intended anatomical regions indicated in this operating manual. Rayscan AI suite is not intended to detect abnormalities from anatomical areas of interest outside the indication for use, the users should review original images for all other suspected pathologies and other anatomical regions and shall rely on their own diagnostic if ever Rayscan AI suite detects abnormalities from anatomical areas outside the indication for use. If Rayscan AI suite encounters an image or an exam outside of the anatomical areas in the instruction for use, it will not be processed by Rayscan AI suite and no Secondary Capture will be generated by Rayscan AI suite. Be careful when you fill in the study description of the exam you perform that the anatomic area of interest is well completed and in the indication for use of the configuration of Rayscan AI suite that you use.
• Poor image quality can affect Rayscan AI suite's detection of abnormality: the users shall proceed to a concurrent read with the original X-ray.
• Rayscan AI suite's features have been optimized and tested to minimize prediction errors, some tolerable residual risks may still exist. The predictions provided by Rayscan AI suite should always be corroborated by a healthcare professional's judgment to ensure correct interpretation of the results and appropriate patient management.

Notes

• Rayscan AI suite is available as different variants for the installation: full cloud, cloud/vm, and on-premise (hardware, server …). If required by the user, Rayscan AI suite can be embedded in hardware, it is not part of the medical device Rayscan AI suite. Embedded in a hardware mode is only available in Europe, any indications related to this hardware/embedded in the instructions are applicable to Europe only.
• Any serious incident occurring in connection with the device should be notified to AZmed and to the competent authority in which the user is established
• In the event of a significant change in Rayscan AI suite's performance, please contact AZmed's support at support@azmed.co
• In case of trouble with the instruction for use in electronic format, AZmed can provide the instruction for use in paper format at no additional cost for the user in 7 days
• Rayscan AI suite is not intended to detect abnormalities in other modalities than CT scans
• The hardware component is not considered part of the medical device. For the proper use and potential risks associated with the hardware components of this device, please refer to our supplier's hardware manual. Any hardware-related risks or issues are the responsibility of the supplier, not AZmed. Should you encounter any problems or concerns regarding the hardware, please notify us immediately. We will coordinate with the supplier to address and resolve the issue promptly.
• The AI system includes an internal logging mechanism that automatically records key information related to each inference, such as the input image reference, timestamp. While these logs are not directly accessible to the client, they are securely stored and maintained by AZmed. If information related to a specific log event is required (e.g. for investigation, traceability or performance review), clients may contact the technical support team at support@azmed.co
• This product integrates artificial intelligence (AI) technology to support medical image analysis. If a user requests not to use the AI functionality, the product will be deactivated and removed from the site, as its core features depend entirely on AI-based processing.
• Prior to the deployment of the software, AZmed provides training sessions to healthcare professionals to present the product, explain how to interpret its outputs, and address any questions regarding its use in practice.

Performances claimed

Based on standalone performance testing and the state-of-the-art, we claim that the Rayscan AI suite helps healthcare professionals by:

• Improving their performance in detecting and localizing early lung nodules (including early lung nodules)
• Enhancing diagnostic consistency
• Provides enhanced characterization of nodule (including contour and composition) to support risk stratification and clinical decisions, in line with international guidelines based on nodules volume (Fleischner Society)
• Reducing the healthcare professionals' workload