Who is the manufacturer of OpenRad Cloud?

Openrad Services Uk, Ltd. filed the 510(k) submission for OpenRad Cloud (K240839).

What is the FDA product code for OpenRad Cloud?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for OpenRad Cloud?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OpenRad Cloud?

3Dnet Suite (K063107); Ambra PACS including Ambra ProViewer (K202335).

Who can help prepare an FDA 510(k) submission like OpenRad Cloud?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OpenRad Cloud

K240839 · Openrad Services Uk, Ltd. · LLZ · Apr 24, 2024 · Radiology

Device Facts

Record ID	K240839
Device Name	OpenRad Cloud
Applicant	Openrad Services Uk, Ltd.
Product Code	LLZ · Radiology
Decision Date	Apr 24, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

Intended Use

OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and any user who requires and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display. The device is not intended for use with mobile displays. Review of images require an optimum display of images. Only use cleared monitors and printers for diagnosis review of images. Follow the maintenance and care instructions given in the manufacturer's documentation.

Device Story

OpenRad Cloud is a client-server software system for display, evaluation, and management of DICOM-compliant medical images (CT, MRI, Mammogram, Ultrasound, etc.). It receives/sends DICOM studies, archives them, and presents them in worklists for clinicians. Users perform 2D/3D visualization, including MPR (orthogonal, oblique, curved), MIP, MinIP, volume rendering, and segmentation. Specialist tools support clinical workflows like Virtual Colonoscopy, Vessel Analysis, Calcium Scoring, PET/CT, CT Lung, CT Dental, and DCE-MRI (Breast/Prostate). Operated by radiologists and healthcare professionals in clinical settings using medical-grade monitors. Output includes visualized images, measurements, annotations, and reports. Cloud-hosted architecture enables remote access and thin-client functionality. Benefits include enhanced diagnostic visualization and streamlined clinical workflows.

Clinical Evidence

No clinical data. Device performance was evaluated through bench-only testing, including unit, system integration, and validation testing. Performance was verified against known results of datasets and compared to predicate device outputs by clinical experts. Verification confirmed that design specifications and predetermined acceptance criteria were met.

Technological Characteristics

Client-server software architecture; cloud-hosted. Supports DICOM 3.0. Features: 2D/3D visualization (MPR, MIP, MinIP, volume rendering), segmentation, measurement, annotation, and reporting. Operates on off-the-shelf hardware with Windows OS. Complies with NEMA XR 22/23, IEC 62562-2, and DICOM standards. Software developed per IEC 62304.

Indications for Use

Indicated for medical image analysis and diagnosis by trained healthcare professionals and medical researchers with knowledge of medical imaging and experience in digital imaging diagnosis and interpretation. Used in hospitals, imaging centers, and reading practices. Not for use with mobile displays.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

3Dnet Suite (K063107)
Ambra PACS including Ambra ProViewer (K202335)

Related Devices

K223048 — Medisystem Pacs · Medilab Manutencao E Sitemas Ltda · Jun 23, 2023
K231360 — Ambra PACS · Dicom Grid Dba Ambra Health · Jun 7, 2023
K203058 — CloudVue · International Medical Solutions, Inc. · Oct 29, 2020
K200546 — ZeeroMED View · O3 Enterprise Srl · May 5, 2020
K082269 — VISAGE PACS, VERSION 6.0/CS 3.1 · Visage Imaging, Inc. · Dec 12, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. OpenRad Services UK Ltd % Eileen Heller Final Reviewer BeanStock Consulting 8885 Rio San Diego Dr. #237 San Diego, California 92108 April 24, 2024 Re: K240839 Trade/Device Name: OpenRad Cloud Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 27, 2024 Received: March 27, 2024 Dear Eileen Heller: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240839 Device Name OpenRad Cloud ### Indications for Use (Describe) OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display. The device is not intended for use with mobile displays. Review of images require an optimum display of images. Only use cleared monitors and printers for diagnosis review of images. Follow the maintenance and care instructions given in the manufacturer's documentation. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510k Summary This summary of 510(k) safety and efficiency information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. #### 1. SUBMITTER OpenRad Services UK Ltd The Old Rectory, Church Street, Weybridge, Surrey, England, KT13 8DE Contact: Thomas Falcon, Head of Compliance Email: thomas.falcon@openrad.com Telephone: (+44) 7780 680864 Date Summary prepared: 19 April 2024 - 2. DEVICE Device trade name: OpenRad Cloud Device common name: Medical Image Processing Software System Classification name: System, image processing, radiological Device Regulation #: 21 CFR 892.2050 Regulatory Class: II Product Code: LLZ - 3. PREDICATE DEVICES: Primary Predicate Device: Manufacturer: Biotronics3D, Trade name: 3Dnet Suite, Premarket Notification #: K063107 Device Product Code & Regulation #: LLZ; 21 CFR 892.2050 Reference Predicate Device: Manufacturer: Dicom Grid, Inc., dba Ambra Health, Trade name: Ambra PACS including Ambra ProViewer Premarket Notification #: K202335 Device Product Code & Regulation #: LLZ; 21 CFR 892.2050 #### 4. DEVICE DESCRIPTION The OpenRad Cloud is a software device for the display and evaluation of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, Mammogram, and Ultrasound scans. OpenRad Cloud principles of operation and its mode of action: - Receive/Send DICOM Studies; 1. - 2. Pre-process and archive in the correct folder; {4}------------------------------------------------ - 3. Display study in the correct worklists for intended users; - 4. Open the study for visualization together with any existing previous studies of the patient; - ഗ് Produce, communicate and archive reports. The system is a client-server based architecture. OpenRad Cloud viewer requires a medical grade monitor for diagnostic reading of images, favouring the use of full radiology workstations. The OpenRad Cloud Software provides several levels of functionality to the user: - Basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar . reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP, MinIP, measurements, annotations, reporting, distribution etc. - . Tools for in-depth analysis, such as segmentation, endoscopic view, color volume rendered slabs, grayscale volume rendered slabs, 3D volume review, path definition and boundary detection. - Specialist tools and workflow enhancements for specific clinical applications which provide targeted workflows, custom UI, measurement and visualisation, including Virtual Colonoscopy, Vessel Analysis, Calcium Scoring, PET/CT, CT Lung Analysis, CT Dental and DCE-MRI Breast and Prostate. The OpenRad Cloud Software product is based on the Biotronics3D 3Dnet product, developed and marketed by Biotronics3D. Biotronics3D was acquired by OpenRad, and 3Dnet will therefore be labelled and marketed in the US as OpenRad Cloud. The original product was previously approved as follows: Manufacturer: Biotronics3D, Trade name: Premarket Notification #: K063107 Device Product Code & Regulation #: LLZ; 21 CFR 892.2050 #### INDICATIONS FOR USE 5. OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and any user who requires and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display. The device is not intended for use with mobile displays. Review of images require an optimum display of images. Only use cleared monitors and printers for diagnosis review of images. Follow the maintenance and care instructions given in the manufacturer's documentation. {5}------------------------------------------------ #### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE DEVICES The OpenRad Cloud Software utilizes the same technological characteristics as the predicate devices Each provides multi-view user interfaces with combinations of 2D and 3D views correlated together for enhanced visualization. Each provides window/level adjustment of the views to enhance features, provide measurement tools for analysis of the observed structures, provide region of interest tools to isolate specific features and provide manual annotation tools to help indicate and describe findings. Each device supports the DICOM protocol for the communication of images with other medical devices. Image modalities are consistent for the display of 2D/3D visualisation of DICOM compliant medical image data, such as CT, MR, PT, US, CR, MG, NM, DX, OT, XA, XR, XC, RF, DR, DS, SR, OCT, PX, ECG, ES, IO modalities, and reporting. The subject device is the next version of the primary predicate device and they are substantially equivalent in the areas of general function, application, and intended use. The subject device is adding a Cloud hosting and thin-client provision function which was not available on the primary predicate but is available on the reference predicate. Any differences between the subject device and the predicates and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices. | Functionality | OpenRad | Biotronics3D Ltd. | Dicom Grid, Inc., dba Ambra Health | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System | OpenRad Cloud Software | 3Dnet Suite (K063107) | Ambra PACS including ProViewer (K202335) | | Indication for use | OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and any user who requires and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and reordering functionality. OpenRad Cloud PACS and Viewer is intended to be used by trained healthcare professionals and medical | The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans. The 3Dnet Suite provides several levels of functionality to the user: - basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgJP, MIP, MinIP, measurements, annotations, reporting, distribution etc. - tools for in-depth analysis, such as | Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. Ambra ProViewer, a component of Ambra PACS, displays, modifies, and manages diagnostic quality DICOM images, including 3D visualization and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for | | Functionality | OpenRad | Biotronics3D Ltd. | Dicom Grid, Inc., dba Ambra Health | | | researchers, with knowledge on medical imaging and experience in digital imaging diagnosis and interpretation Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display. The device is not intended for use with mobile displays. Review of images require an optimum display of images. Only use cleared monitors and printers for diagnosis review of images. Follow the maintenance and care instructions given in the manufacturer's documentation. | segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc. - Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, targeted measurement and visualization, including colon screening which is indented for the screening of patients for colonic polyps, tumors and other lesions using tomographic colonography. | mammography display. Not intended for diagnostic use on mobile devices. | | Functions | • Image input, storage, view, annotate • 2D/3D image viewing • Segmentation • Measurements • Data Analysis • Multi-Planar reformatting (MPR) • Volume rendering • Maximum Intensity Projection (MIP) • Image Editing • Printing | • 2D/3D image viewing • Segmentation • Measurements • Data Analysis • Multi-Planar reformatting (MPR) • Volume rendering • Maximum Intensity Projection (MIP) • Image Editing • Printing | Ambra ProViewer, a component of Ambra PACS, imports, displays, modifies, and manages diagnostic quality DICOM images, including 3D visualization and reordering. | | Data Source | MR, CT, 3D US scanners | MR,CT,3D US scanners | MR, CT, 3D US scanners | | Physical Characterization | • Operates on off- the-self hardware • Windows OS • DICOM compatible | • Operates on off- the- self hardware • Windows OS • DICOM compatible | • Operates on off- the-self hardware • Windows OS • DICOM compatible | | Functionality | OpenRad | Biotronics3D Ltd. | Dicom Grid, Inc., dba Ambra Health | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ # Technical Characteristics | Characteristic | OpenRad Cloud PACS | Biotronics3D Ltd. | Intelerad Ambra PACS including ProViewer | Difference? | |----------------------------------------------------------|-----------------------|----------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Basic Tools | | | | | Thin client/ Zero client | Y | Y | Y | These features were provided in Biotronic 3Dnet as a Windows application. These features are provided in both OpenRad Cloud and Ambra Viewer as Cloud applications. | | Measurements and annotations | Y | Y | Y | | | Dynamic hanging protocols | Y | Y | Y | | | Comparative mode and sync navigation | Y | Y | Y | | | Zoom, pan, invert, flip, cine mode, W/L | Y | Y | Y | | | Reporting | Y | Y | Y | | | CT Colonography | Y | Y | Y | | | CTLung | Y | Y | Y | | | CTVessel | Y | Y | Y | | | CT Calcium Scoring | Y | Y | Y | | | CTDental | Y | Y | Y | | | BreastMRI | Y | Y | Y | | | Mammography | Y | Y | Y | | | X-ray Angiography (XA) | Y | Y | Y | | | DCE-MRI | Y | | | Does not raise new questions of safety and effectiveness. Validated during performance testing | | ADC Map | Y | | | ADC mapping is a minor visualisation tool common in DICOM viewers. Does not raise new questions of safety and effectiveness. Validated during performance testing | | Spine Labelling | Y | | | This is a manual annotation tool, common in DICOM | | | | | | viewers, which users access and apply exactly as they do other annotation tools. | | Prostate | Y | | | Viewer functionality. Does not raise new questions of safety and effectiveness. Validated during performance testing | | Advanced and Specialist Visualisation Tools | | | | | | Multiplanar Reconstruction (MPR) (curved and oblique) | Y | Y | Y | These features were provided in Biotronic 3Dnet as a Windows | | PET / CT | Y | Y | Y | application. These features are provided in both OpenRad Cloud and Ambra Viewer as Cloud applications. | | 3D Volume | Y | Y | Y | | | Maximum Intensity Projection MIP | Y | Y | Y | | | Slab MIP / Sliding Thin Slab (STS) | Y | Y | Y | | | MeanMIP/AvgMIP, MinIP | Y | Y | Y | | | Reorder Series | Y | Y | Y | | {8}------------------------------------------------ {9}------------------------------------------------ | Functionality | OpenRad Cloud PACS | Biotronics3D Ltd. | Intelerad Ambra PACS including ProViewer | Difference? | |----------------------------|-----------------------|-------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User interaction/input | Y | Y | Y | No difference, | | Import / export images | Y | Y | Y | These features were provided in Biotronics 3Dnet as a Windows application. These features are provided in both OpenRad Cloud and Ambra Viewer as Cloud applications. | | Image search available | Y | Y | Y | | | Image storage | Y | Y | Y | | | Image annotation | Y | Y | Y | | | DICOM 3.0 compatibility | Y | Y | Y | | | Thumbnail viewing | Y | Y | Y | | | Panning | Y | Y | Y | | | Magnify glass | Y | Y | Y | | | Fit image | Y | Y | Y | | | Cloud hosting | Y | N | Y | Does not raise new questions of safety and effectiveness. Tested as part of software verification and validation | We conclude that the subject device, the OpenRad Cloud Software, is as safe and effective as the predicate devices and poses no new questions of safety and effectiveness. #### 7. PERFORMANCE DATA & CLINICAL EVALUATION The OpenRad Cloud Software has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols. The proposed use indications were evaluated through unit, system, and validation testing under established company {10}------------------------------------------------ protocols for design specifications and requirements, subsequent risk management analysis, and final design review. The device performance as documented in the verification report affirms design specifications are met and with a profile similar to the predicate device by clinical experts using the same methodology and datasets as the ones used for in-house tests. The evaluation outcome was based on their clinical experience and verifying the outputs against the known results of the datasets and the proposed transfer functions and parameters when used in other similar devices. Validated performance claims are associated with the intended use only, and clinical equivalence is aligned with that of the predicate device. ## Non-clinical Testing The OpenRad Cloud Software has been assessed and tested in-house and has passed all predetermined testing criteria. The Validation and Validation Plan and Clinical Evaluation Plan were designed to evaluate input functions, output functions, and actions performed by OpenRad Cloud Software, and followed the process documented in the respective plan. Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. #### 8. STANDARDS: The following were used in the development of the OpenRad Cloud Software, in which the device meets the requirements set forth in the standards: a. NEMA XR 22-2006 (R2020): "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography b. NEMA XR 23-2006 (R2020): "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography c. IEC 10918 First edition 1994-02-15: Information technology – Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] d. IEC 62562-2 Edition 1.0 2021-11: Medical electrical equipment – Medical image display systems – Part 2: Acceptance and constancy tests for medical image displays e. Public law 104-191 Congress of the United States of America, Health Insurance Portability f. 45 CFR Part 160 & 164 U.S. Department of Health & Human Services, Summary of the HIPAA Security Rule g. 12-342 NEMA PS 3.1 - 3.20 2021e Digital Imaging and Communications in Medicine (DICOM) Set h. 12-349 NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set i. ISO 14971:2019 IEC62304: 2015 j. 21 CFR Part 820 - Quality System Regulation k. FDA-1997-D-0029 - General Principles of Software Validation {11}------------------------------------------------ l. FDA-2011-D-0469 - Applying Human Factors and Usability Engineering to Medical Devices m. FDA-2013-D-0616 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices n. FDA-2015-D-5105 - Postmarket Management of Cybersecurity in Medical Devices o. FDA-2016-D-2483 Software as a Medical Device (SAMD): Clinical Evaluation p. FDA-2020-D-0957 - FDA Guidance for Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) q. IEC 62304:2006/Amd 1:2015 - Medical device software - Software life cycle processes r. IEC 62366-1:2015/Amd 1:2020 - Application of usability engineering to medical devices s. ISO 13485:2016 - Quality Management Systems t. ISO 14971:2019 - Medical devices - Application of risk management to medical devices ## 9. CONCLUSION The OpenRad Cloud Software has similar indications for use and technological characteristics as the 3DNET SUITE and Ambra PACS including ProViewer. OpenRad Cloud Software does not raise any new questions of safety or effectiveness and is equivalent in performance to existing, legally marketed devices. We conclude from these tests that OpenRad Cloud Software is substantially equivalent to the predicated devices. Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.