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.

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 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.

Available 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.

AI/ML Overview

The provided document, a 510(k) Premarket Notification from RamSoft Inc. for their OmegaAI Image Viewer, details the device's indications for use, its comparison to predicate devices, and a summary of software validation and verification testing. However, it does not contain specific information about acceptance criteria or a dedicated study proving the device meets those criteria, particularly in the context of clinical performance like human-in-the-loop improvements with AI assistance or standalone algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology, and basic functional capabilities (image manipulation, display of various modalities, architecture, HIPAA compliance, etc.). The "Software Validation and Verification Testing Summary" on page 12 describes typical software quality assurance tests (regression tests, bug fix verification) rather than a clinical performance study with human readers or AI.

Therefore, many of the requested elements for describing the acceptance criteria and a study proving device performance (especially those related to clinical effectiveness, human reader performance, or standalone AI performance) cannot be extracted from this document.

Here is what can be inferred or stated based on the provided text, with a clear indication of what is not present:

Missing Information/Cannot be Extracted from the Provided Document:

A table of acceptance criteria and reported device performance: The document does not provide a formal table of acceptance criteria for clinical performance metrics or specific reported performance data beyond functional verification.
Sample size used for the test set and data provenance (e.g. country of origin of the data, retrospective or prospective): No information on a test set (in a clinical performance context), sample size, or data provenance is provided.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable, as no such clinical test set or ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study is described. The device is an image viewer, not explicitly stated to have integrated AI for diagnostic findings that would necessitate an MRMC study measuring AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the document does not describe a standalone AI algorithm's performance. The device is a viewer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth establishment is described.
The sample size for the training set: Not applicable, as no AI model training is described.
How the ground truth for the training set was established: Not applicable.

What can be extracted or inferred from the document regarding "acceptance criteria" and "study":

The "acceptance criteria" and "study" described in this 510(k) summary are primarily focused on software validation and verification to ensure the device functions as intended and is substantially equivalent to predicate devices, rather than clinical performance metrics for a novel diagnostic algorithm.

1. A table of acceptance criteria and the reported device performance:

While no formal table of performance criteria like sensitivity/specificity is provided, the document implies the following "acceptance criteria" through its software validation process:

Acceptance Criteria (Implied from Software V&V)	Reported Device Performance (Summary)
Functional Correctness	Full regression tests executed on major features to uncover potential bugs.
	Bug fix verification for reported issues and regression tests on related features.
	Full regression tests executed on the candidate build for release to verify all functionalities and fixes.
Safety and Risk Mitigation	"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."
Substantial Equivalence	Device performs comparably to predicate devices (Nucleus.io K203249 and RapidResults K141881) in intended use and core viewing functionalities.
Compliance	Software Verification and Validation Testing was conducted as recommended by FDA guidance for software in medical devices.

2. Sample size used for the test set and the data provenance:

The document refers to "test cases" used in software verification. It does not specify a sample size for these test cases (e.g., number of images, patient cases).
Data Provenance: Not specified. The testing described is typical software quality assurance (functional, regression testing), not a clinical trial using specific patient data sets. The origin of any images used for testing is not mentioned.
Retrospective/Prospective: Not specified. Given it's software testing, it's typically done in a controlled, simulated/internal environment, not a prospective clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical test set requiring expert ground truth establishment is described. The "verification" was performed by "members of the QA team," whose qualifications are not detailed beyond their role.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The testing described is software quality assurance, not diagnostic performance evaluation requiring reader adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not described. The OmegaAI Image Viewer is presented as a medical image management and processing system (MIMPS), a viewing tool, not an AI diagnostic algorithm that directly assists in human diagnostic reads in a quantifiable way requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not described. The device is an image viewer, not a distinct AI algorithm providing diagnostic outputs. While it "can display annotations and measurements... from Computer-Aided Diagnosis (CAD) and AI software," it is not that CAD/AI software itself, nor does the document describe a study of its own inherent AI capabilities (if any exist beyond displaying external AI outputs).

7. The type of ground truth used:

For the software validation and verification, the "ground truth" would be the expected functional behavior and output of the software as defined by its specifications and design documents. This is not clinical ground truth (e.g., pathology, follow-up outcomes).

8. The sample size for the training set:

Not applicable. The document does not describe the development or training of an AI algorithm within the OmegaAI Image Viewer.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

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 (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 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)

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

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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:

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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: +1 647-797-2745 dshukla@ramsoft.com 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

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.

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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

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.

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
RegulationNumber, 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 forUse	OmegaAI Image Viewer is softwarefor diagnostic and clinical reviewintended for use in GeneralRadiology (images from modalitiesincluding CR, CT, DX, MR, MG,NM, US, PET, RG, SC, VL, XA,Film Digitizer), InterventionalRadiology, cardiology, oncology,obstetrics and gynecology,gastroenterology, ENT, orthopedics,internal medicine, emergencymedicine, dermatology, dentistry,cardiology, rheumatology,Pathology (i.e., to review capturedimages/videos from a sample) andother healthcare imagingapplications.OmegaAI Image Viewer is intendedto be used with off the shelfcomputing devices. Displaymonitors used for reading medicalimages for diagnostic purposes mustcomply with applicable clinicalrequirements, regulatory approvalsand with quality controlrequirements for their use andmaintenance. With appropriatedisplay monitors, lighting, imagequality, and level of lossy imagecompression, the OmegaAI ImageViewer is intended for diagnosticpurposes (on desktop platforms) andas a non-diagnostic review tool (onmobile platforms) to be used bytrained healthcare professionals.Display calibration and lightingconditions should be verified byviewing a test pattern prior to use	This software displaysmedical images andassociated documents. Withappropriate display monitors,lighting, image quality, andlevel of lossy imagecompression, the software isintended for use as a primarydiagnostic and review tool foruse by trained healthcareprofessionals.Each healthcare professionalmust determine if the level ofloss is acceptable for theirpurpose. This software is notsuitable for primary diagnosisof mammograms.Caution: Federal lawrestricts this device to sellby or on the order of aphysician.	Nucleus.io is a software-based image managementsolution and PACS intendedto be used by radiologists andother clinicians. Nucleus.ioprovides image receipt,diagnostic viewing, storage,distribution, enhancement,sharing, manipulation (markup and adjustment tools), andnetworking of medical 2D/3Dimages at distributedlocations. All modules ofNucleus.io are web-based andthus can operate completelyremote.Nucleus.io displays bothlossless and lossy compressedimages. For lossy images, themedical processional usermust determine if the level ofloss is acceptable for theirpurposes.Display monitors used forreading medical images fordiagnostic purposes mustcomply with applicableregulatory approvals andwith quality controlrequirements for their useand maintenance.

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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Toll Free: +1 888.343.9146 Fax: +1 416.674.7147

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

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reports side by side with the images.This can be used side by side with areporting tool to create diagnosticreports.Note: To protect confidentialinformation and ensure datasecurity, the OmegaAI ImageViewer has User Access Control(UAC) which preventsunauthorized access andmodification of data.OmegaAI Image Viewer runs in aweb browser sand-box, thus itrelies on the browser's handling ofinterruptions, low-memoryconditions etc. The browser willgive an error to the user when it isnot able to perform due to aninterruption.Caution: Federal law restricts thisdevice to sell by or on the order ofa physician.			Toll Free: +1 888.343.9146Fax: +1 416.674.7147
Intended Use	The OmegaAI Image Viewer isintended for diagnostic purposesand to be used as a review tool.	Primary diagnostic andreview tool.This software is not suitablefor primary diagnosis ofmammograms.	Nucleus.io is intended fordiagnostic purposes and to beused as a review tool.
Imagemanipulationfeatures	Adjustment Tools:Window level, rotate, flip, pan,stack roll, and zoom.Markup Tools:Annotate, angle, cobb angle,probe, Mark ROI, andmeasurement.	Window/Level, Zoom,Rotation, Flip, Pan,Measure, andAnnotation.RapidResultsdoes notproduce or alter anyimages and medicaldata.	Window/level, flip/rotation,zoom, pan, measurement andMark ROI.
RamSoft, Inc.			©1994-2022 RamSoft Inc.
HIPAACompliance	OmegaAI Image Viewerconnects to the PACS usingHTTPS.OmegaAI Image Viewer doesnot store images on any user'sdevice. Images are stored in thePACS, not on the device.When the web browser ormobile application is closed, allimages and information aregone from the device.	The Viewer secured connectsto the PACS using HTTPSImages stay in the PACS, noton the device. When the webbrowser or mobile applicationis closed, all images andinformation are gone from thedevice. RapidResults does notstore images on any user'sdevice.	Nucleus.io connects to thePACS using HTTPS.Images are stored in thePACS, not on the device.When the web browser ormobile application is closed,all images and informationare gone from the device.Nucleus.io does not storeimages on any user's device.
SupportModalities	View all image modalities,including CR, CT, DX, MR,MG, NM, US, PET, RG, SC,VL, XA, PET, and FilmDigitizer.	View all image modalities,including X-ray, CT, MRI,color ultrasound and X-Rayangiography.	View all image modalities,including CR, CT, DX, MR,MG, NM, RF, US, and XA.
Architecture	Server-based software solutionthat displays images andreports from a PACS using azero-footprint application(browser).No installation is needed.	Server-based softwaresolution that display imagesand reports from a PACSusing a zero-footprintapplication (HTML5)	Server-based softwaresolution that displays medicalimages and reports from asite's existingimage archives (radiology,cardiology & other PACS andVNA systems), using a zero-footprint application(browser).No installation needed.
Technology	Use of various technologystandards (LDAP, SSO,HTTPS, HTML, HL-7Integration web services, etc.)	Use of various technologystandards (LDAP, SSO,HTTPS, HTML, HTML5,CSS, XML, web services,etc.)	Use of various technologystandards (LDAP, HTTPS,HTML, HL-7 Integration webservices, etc.)
SupportPlatforms,Devices	Supports major desktop (fordiagnostic purposes) andmobile platforms (for non-diagnostic purposes; can beused as a review tool) such asMicrosoft Edge, Chrome,Safari, Apple iOS, Android,Windows and Mac devices.	Support major desktop andmobile browsers such asInternet Explorer 10.0 orhigher, Chrome, and Safari;on Apple iOS, Android,Windows Mobile, andBlack Berry devices.	Supports major desktop andmobile browsers such asChrome, and Safari; on AppleiOS, Android, WindowsMobile 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.

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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)

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).