OmegaAI Image Viewer

K222476 · Ramsoft, Inc. · LLZ · Nov 17, 2022 · Radiology

Device Facts

• Record ID: K222476
• Device Name: OmegaAI Image Viewer
• Applicant: Ramsoft, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

OmegaAI Image Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR, CT, DX, MR, MG, NM, US, PET, RG, SC, VL, XA, Film Digitizer), Interventional Radiology, oncology, obstetrics and gynecology, gastroenterology, ENT, orthopedics, internal medicine, dermatology, dentisty, cardiology, theumatology, Pathology (i.e., to review captured images videos from a sample) and other healthcare imaging applications. OmegaAI Image Viewer is intended to be used with off the shelf computing devices used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, regulatory approvals and with quality control requirements for their use and maintenance. With appropriate display monitors, image quality, and level of lossy image compression, the OnegaAl Image Viewer is intended for diagnostic purposes (on desktop platforms) and as a non-diagnostic review tool (on mobile platforms) to be used by trained healthcare professionals. Display calibrations should be verified by viewing a test pattern prior to use for diagnostic purposes.

Device Story

OmegaAI Image Viewer is a web-based, zero-footprint software application for viewing and manipulating medical images/videos from various modalities (CR, CT, MR, US, etc.). It operates within a web browser sandbox on off-the-shelf desktop and mobile devices. Users (radiologists, technologists, clinicians) access images via HTTPS from a PACS; no images are stored locally on the device. The viewer provides adjustment tools (window/level, zoom, pan, rotation) and markup tools (annotations, measurements, ROI). It supports 3D rendering (MPR, MIP, VR) and displays overlays from CAD/AI software. It allows side-by-side viewing of images and clinical reports to aid diagnostic decision-making. By providing remote, secure access to diagnostic-quality images, it facilitates timely clinical review and reporting, potentially improving patient care workflows.

Clinical Evidence

Bench testing only. Verification and validation testing included full regression testing and bug fix verification conducted by the QA team. The software was evaluated against functional requirements to ensure diagnostic accuracy and reliability. No clinical trials were performed.

Technological Characteristics

Server-based, zero-footprint web application. Supports standard web browsers (Chrome, Safari, Edge). Connectivity via HTTPS; integrates with PACS using HL7 and web services. Supports DICOM presentation states. Features 3D processing (MPR, MIP, VR). Software level of concern: Moderate. Security includes User Access Control (UAC).

Indications for Use

Indicated for trained healthcare professionals to perform diagnostic and clinical review of medical images/videos across various specialties including radiology, cardiology, oncology, and pathology. Intended for diagnostic use on desktop platforms and non-diagnostic review on mobile platforms. Contraindicated for primary reading of mammography using lossy image compression.

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

• Nucleus.io (K203249)
• RapidResults (K141881)

Submission Summary (Full Text)

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RamSoft Inc. % Deeksha Shukla Compliance & Legal Officer 150 Wheeler Avenue Toronto. Ontario M4L 3V4 CANADA

Re: K222476

November 17, 2022

Trade/Device Name: OmegaAI Image Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 7, 2022 Received: October 7, 2022

Dear Deeksha Shukla:

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 (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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K222476

#### Device Name: OmegaAI Image Viewer

Indications for Use (Describe)

OmegaAI Image Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR, CT, DX, MR, MG, NM, US, PET, RG, SC, VL, XA, Film Digitizer), Interventional Radiology, oncology, obstetics and gynecology, gastroenterology, ENT, orthopedics, internal medicine, dermatology, dentisty, cardiology, theumatology, Pathology (i.e., to review captured images videos from a sample) and other healthcare imaging applications.

OmegaAI Image Viewer is intended to be used with off the shelf computing devices used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, regulatory approvals and with quality control requirements for their use and maintenance. With appropriate display monitors, image quality, and level of lossy image compression, the OnegaAl Image Viewer is intended for diagnostic purposes (on desktop platforms) and as a non-diagnostic review tool (on mobile platforms) to be used by trained healthcare professionals. Display calibrations should be verified by viewing a test pattern prior to use for diagnostic purposes.

OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Android, Windows. OmegaAI Image Viewer displays both lossy compressed images. Each healthcare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression acceptable for their purpose. Lossy image compression should not be used for primary reading in mammography.

OmegaAI Image Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. OnegaAl Image Viewer can be used to verify images that are captured in a medical imaging system have a diagnostic quality, to correct viewing characteristics of the image such as oriention, contrast, as well as to add annotations to mark significant finding or provide guidance for radiologists.

OmegaAI Image Viewer can store annotation as DICOM presentation states without changing the original image data. OmegaAI Image Viewer can display and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software, The viewer can perform 3D Multi-Planer (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). OmegaAl In reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reate diagnostic reports.

#### Note: To protect confidential information and ensure data security, the OmegaAI Image Viewer has User Access Control (UAC) which prevents unauthorized access and modification of data.

OmegaAI Image Viewer runs in a web browser sand-box, thus it relies on the browser's handling of internory conditions etc. The browser will give an error to the user when it is not able to perform due to an interruption.

Caution: Federal law restricts this device to sell by or on the order of a physician.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/5/Picture/0 description: The image shows the logo for RamSoft. The word "Ram" is in gray, and the word "Soft" is in red. Below the company name is the phrase "GLOBAL IMAGING DELIVERED" in gray.

# 510(k) Summarv

# K222476

#### Statement

The following information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements... " (21 CFR 807.92) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

#### Submitter General Company Information

Company: RamSoft, Inc. Contact: Deeksha Shukla Address: 150 Wheeler Avenue, Toronto ON M4L 3V4, Canada Phone: [phone] [e-mail] Email:

#### Device:

Trade Name: OmegaAI Image Viewer Classification Name: Medical Image Management and Processing System (MIMPS)(21 CFR 892.2050) Regulatory Class: II Product Code: LLZ- Image Processing System 510(k) Number: K222476

# Predicate Devices

510(k) Number: K203249 Device Name: Nucleus.io Company: Nucleus Health, LLC

510(k) Number: K141881 Device Name: RapidResults Company: RamSoft Inc.

Date Prepared: August 11, 2022.

#### General Device Description

OmegaAl Image Viewer is designed to view and manipulate medical images or videos created from diagnostic imaging systems such as X-ray, Computed tomography, Nuclear medicine, MRI, Ultrasound, laboratory systems, and images from other sources such as handheld devices and cameras, endoscopy or other sources of images and videos. It can perform various image manipulation activities and store the modifications as presentation state along with the original study for future reference. OmegaAI Image Viewer allows users to perform image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack scroll, and magnify. Notably, users have access to Markup Tools such as annotate, angle, probe, Mark ROI, and measurement. OmegaAI Image Viewer is also capable of organizing all the captured images for a patient and

RamSoft. Inc. 150 Wheeler Avenue Toronto ON M4L 3V4 www.RamSoft.com

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presenting them in a zero-footprint, web user interface, allowing the users to view images in their preferred layout and enabling them to compare current images with prior images of the respective patient.

A vailable on popular mobile and desktop platforms with keyboard, mouse, and touch inputs, the OmegaAl I Image Viewer provides access to medical images in a convenient way for health care professionals to use as a diagnostic viewer and for review purposes.

OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Apple iOS, Android, Windows and Mac devices. The software can only be used for diagnostic purposes on desktop platforms, whereas on mobile platforms it can be utilized as a non-diagnostic review tool by trained health professionals.

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Image /page/7/Picture/0 description: The image shows the logo for RamSoft. The word "Ram" is in gray, and the word "Soft" is in red. Below the company name is the text "GLOBAL IMAGING DELIVERED" in gray.

## Indication for Use

OmegaAI Image Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR, CT, DX, MR, MG, NM, US, PET, RG, SC, VL, XA, Film Digitizer), Interventional Radiology, cardiology, oncology, obstetrics and gynecology, ENT, orthopedics, internal medicine, emergency medicine, dermatology, dentistry, cardiology, Pathology (i.e., to review captured images/videos from a sample) and other healthcare imaging applications.

OmegaAI Image Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, regulatory approvals and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the OmegaAI Image Viewer is intended for dagnostic purposes (on desktorms) and as a non-diagnostic review tool (on mobile platforms) to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes.

OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Apple iOS, Android, Windows. OmegaAI Image Viewer displays both lossy compressed images. Each healtheare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression for their purpose. Lossy image compression should not be used for primary reading in mammography.

OmegaAI Image Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. OmegaAI Image Viewer can be used to verify images that are captured in a medical imaging system have a diagnostic quality, to correct viewing characteristics of the image such as orientation, contrast, as well as to add annotations to mark significant finding or provide guidance for radiologists.

OmegaAI Image Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. OmegaAI Image Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). OmegaAl Image Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reporting tool to create diagnostic reports.

Note: To protect confidential information and ensure data security, the OmegaAl Image Viewer has User Access Control (UAC) which prevents unauthorized access and modification of data.

OmegaAI Image Viewer runs in a web browser sand-box, thus it relies on the browser's handling of interruptions, low-memory conditions etc. The browser will give an error to the user when it is not able to an interruption.

Caution: Federal law restricts this device to sell by or on the order of a physician.

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# Comparison with the Predicate Device

| Characteristics | Subject Device | Predicate Device | Predicate Device |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | OmegaAI Image Viewer | RapidResults | Nucleus.io |
| Manufacturer | RamSoft Inc. | RamSoft Inc. | Nucleus Health, LLC |
| 510(k) Number | K222476 | K141881 | K203249 |
| Regulation<br>Number, Class | 21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II |
| Product Code | LLZ | LLZ | LLZ |
| Indication for<br>Use | OmegaAI Image Viewer is software<br>for diagnostic and clinical review<br>intended for use in General<br>Radiology (images from modalities<br>including CR, CT, DX, MR, MG,<br>NM, US, PET, RG, SC, VL, XA,<br>Film Digitizer), Interventional<br>Radiology, cardiology, oncology,<br>obstetrics and gynecology,<br>gastroenterology, ENT, orthopedics,<br>internal medicine, emergency<br>medicine, dermatology, dentistry,<br>cardiology, rheumatology,<br>Pathology (i.e., to review captured<br>images/videos from a sample) and<br>other healthcare imaging<br>applications.<br><br>OmegaAI Image Viewer is intended<br>to be used with off the shelf<br>computing devices. Display<br>monitors used for reading medical<br>images for diagnostic purposes must<br>comply with applicable clinical<br>requirements, regulatory approvals<br>and with quality control<br>requirements for their use and<br>maintenance. With appropriate<br>display monitors, lighting, image<br>quality, and level of lossy image<br>compression, the OmegaAI Image<br>Viewer is intended for diagnostic<br>purposes (on desktop platforms) and<br>as a non-diagnostic review tool (on<br>mobile platforms) to be used by<br>trained healthcare professionals.<br>Display calibration and lighting<br>conditions should be verified by<br>viewing a test pattern prior to use | This software displays<br>medical images and<br>associated documents. With<br>appropriate display monitors,<br>lighting, image quality, and<br>level of lossy image<br>compression, the software is<br>intended for use as a primary<br>diagnostic and review tool for<br>use by trained healthcare<br>professionals.<br><br>Each healthcare professional<br>must determine if the level of<br>loss is acceptable for their<br>purpose. This software is not<br>suitable for primary diagnosis<br>of mammograms.<br><br>Caution: Federal law<br>restricts this device to sell<br>by or on the order of a<br>physician. | Nucleus.io is a software-<br>based image management<br>solution and PACS intended<br>to be used by radiologists and<br>other clinicians. Nucleus.io<br>provides image receipt,<br>diagnostic viewing, storage,<br>distribution, enhancement,<br>sharing, manipulation (mark<br>up and adjustment tools), and<br>networking of medical 2D/3D<br>images at distributed<br>locations. All modules of<br>Nucleus.io are web-based and<br>thus can operate completely<br>remote.<br><br>Nucleus.io displays both<br>lossless and lossy compressed<br>images. For lossy images, the<br>medical processional user<br>must determine if the level of<br>loss is acceptable for their<br>purposes.<br><br>Display monitors used for<br>reading medical images for<br>diagnostic purposes must<br>comply with applicable<br>regulatory approvals and<br>with quality control<br>requirements for their use<br>and maintenance. |

150 Wheeler Avenue Toronto ON M4L 3V4 www.RamSoft.com

All Rights Reserved

RamSoft, Inc. reserves the right to make changes contained herein or discontinue the product described without notice or obligation.

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#### Toll Free: +1 888.343.9146 Fax: [phone]

Image /page/9/Picture/1 description: The image shows the logo for RamSoft. The word "Ram" is in dark gray, and the word "Soft" is in red. Below the word "RamSoft" is the phrase "GLOBAL IMAGING DELIVERED" in a smaller, gray font.

#### for diagnostic purposes.

OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Apple iOS, Android, Windows. OmegaAI Image Viewer displays both lossless and lossy compressed images. Each healthcare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression acceptable for their purpose. Lossy image compression should not be used for primary reading in mammography.

OmegaAI Image Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. OmegaAI Image Viewer can be used to verify images that are captured in a medical imaging system have a diagnostic quality, to correct viewing characteristics of the image such as orientation, rotation, contrast, as well as to add annotations to mark significant finding or provide guidance for radiologists.

OmegaAI Image Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. OmegaAI Image Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). OmegaAI Image Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and

RamSoft. Inc. 150 Wheeler Avenue Toronto ON M4L 3V4 www.RamSoft.com

©1994-2022 RamSoft Inc. All Rights Reserved

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| reports side by side with the images.<br>This can be used side by side with a<br>reporting tool to create diagnostic<br>reports.<br><br>Note: To protect confidential<br>information and ensure data<br>security, the OmegaAI Image<br>Viewer has User Access Control<br>(UAC) which prevents<br>unauthorized access and<br>modification of data.<br><br>OmegaAI Image Viewer runs in a<br>web browser sand-box, thus it<br>relies on the browser's handling of<br>interruptions, low-memory<br>conditions etc. The browser will<br>give an error to the user when it is<br>not able to perform due to an<br>interruption.<br><br>Caution: Federal law restricts this<br>device to sell by or on the order of<br>a physician. | | | Toll Free: +1 888.343.9146<br>Fax: [phone] |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The OmegaAI Image Viewer is<br>intended for diagnostic purposes<br>and to be used as a review tool. | Primary diagnostic and<br>review tool.<br><br>This software is not suitable<br>for primary diagnosis of<br>mammograms. | Nucleus.io is intended for<br>diagnostic purposes and to be<br>used as a review tool. |
| Image<br>manipulation<br>features | Adjustment Tools:<br>Window level, rotate, flip, pan,<br>stack roll, and zoom.<br><br>Markup Tools:<br>Annotate, angle, cobb angle,<br>probe, Mark ROI, and<br>measurement. | Window/Level, Zoom,<br>Rotation, Flip, Pan,<br>Measure, and<br>Annotation.<br>RapidResultsdoes not<br>produce or alter any<br>images and medical<br>data. | Window/level, flip/rotation,<br>zoom, pan, measurement and<br>Mark ROI. |
| RamSoft, Inc. | | | ©1994-2022 RamSoft Inc. |
| HIPAA<br>Compliance | OmegaAI Image Viewer<br>connects to the PACS using<br>HTTPS.<br>OmegaAI Image Viewer does<br>not store images on any user's<br>device. Images are stored in the<br>PACS, not on the device.<br>When the web browser or<br>mobile application is closed, all<br>images and information are<br>gone from the device. | The Viewer secured connects<br>to the PACS using HTTPS<br>Images stay in the PACS, not<br>on the device. When the web<br>browser or mobile application<br>is closed, all images and<br>information are gone from the<br>device. RapidResults does not<br>store images on any user's<br>device. | Nucleus.io connects to the<br>PACS using HTTPS.<br>Images are stored in the<br>PACS, not on the device.<br>When the web browser or<br>mobile application is closed,<br>all images and information<br>are gone from the device.<br>Nucleus.io does not store<br>images on any user's device. |
| Support<br>Modalities | View all image modalities,<br>including CR, CT, DX, MR,<br>MG, NM, US, PET, RG, SC,<br>VL, XA, PET, and Film<br>Digitizer. | View all image modalities,<br>including X-ray, CT, MRI,<br>color ultrasound and X-Ray<br>angiography. | View all image modalities,<br>including CR, CT, DX, MR,<br>MG, NM, RF, US, and XA. |
| Architecture | Server-based software solution<br>that displays images and<br>reports from a PACS using a<br>zero-footprint application<br>(browser).<br>No installation is needed. | Server-based software<br>solution that display images<br>and reports from a PACS<br>using a zero-footprint<br>application (HTML5) | Server-based software<br>solution that displays medical<br>images and reports from a<br>site's existing<br>image archives (radiology,<br>cardiology & other PACS and<br>VNA systems), using a zero-<br>footprint application<br>(browser).<br>No installation needed. |
| Technology | Use of various technology<br>standards (LDAP, SSO,<br>HTTPS, HTML, HL-7<br>Integration web services, etc.) | Use of various technology<br>standards (LDAP, SSO,<br>HTTPS, HTML, HTML5,<br>CSS, XML, web services,<br>etc.) | Use of various technology<br>standards (LDAP, HTTPS,<br>HTML, HL-7 Integration web<br>services, etc.) |
| Support<br>Platforms,<br>Devices | Supports major desktop (for<br>diagnostic purposes) and<br>mobile platforms (for non-<br>diagnostic purposes; can be<br>used as a review tool) such as<br>Microsoft Edge, Chrome,<br>Safari, Apple iOS, Android,<br>Windows and Mac devices. | Support major desktop and<br>mobile browsers such as<br>Internet Explorer 10.0 or<br>higher, Chrome, and Safari;<br>on Apple iOS, Android,<br>Windows Mobile, and<br>Black Berry devices. | Supports major desktop and<br>mobile browsers such as<br>Chrome, and Safari; on Apple<br>iOS, Android, Windows<br>Mobile devices. |

150 Wheeler Avenue
Toronto ON M4L 3V4 www.RamSoft.com

RamSoft, Inc. reserves the right to make changes contained herein or discontinue the product described without notice or obligation.

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Image /page/11/Picture/0 description: The image shows the logo for RamSoft. The word "Ram" is in gray, and the word "Soft" is in red. Below the words is the phrase "GLOBAL IMAGING DELIVERED" in gray.

All Rights Reserved

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Image /page/12/Picture/0 description: The image is a logo for RamSoft. The word "Ram" is in a dark gray color, while the word "Soft" is in red. Below the company name is the text "GLOBAL IMAGING DELIVERED" in a smaller, gray font.

### Conclusion

Based upon the 510(k) summary and 510(k) statement (21 CFR 807) and the information provided herein, we conclude that the subject device is sustainably equivalent to the predicate devices (Nucleus.io K203249 and Rapid Results K141881) under the Federal Food, Drug and Cosmetic Act.

#### Software Validation and Verification Testing Summary

The performance data provided in the form of test cases as well as validation test reports conducted on the OmegaAI Image Viewerinclude the following:

The verifications of features and major fixes were performed by members of the QA team. The verification of the product OmegaAI Image Viewer has been performed with the following steps

- Full regression tests have been executed on the build with the implementations of all major features. The purpose of this test phase is to uncover as much as possible all the potential bugs that could be detected by QA's test scripts. The "Full Regression" test plan is used during this testing cycle.
- Bug fix verification for reported issues and regression test on related features, "Quick Test" test plan is used during the test execution on the build: 5a5d485a7754cee49396e6084b884bfc4b7271b8.
- Full regression tests have been executed on the candidate build for the release to verify all functionalities and fixes.

#### Conclusion of Software Validation and Verification Testing

Software Verification and Validation Testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." In conclusion, the OmegaAI Image Viewer is considered a "moderate" level of concern since a failure or latent flaw in the software could result in an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. This indicates that the subject device is sustainably equivalent to the predicate devices (Nucleus.io K203249 and Rapid Results K141881)