(93 days)
Not Found
Yes
The document explicitly states that the viewer can display annotations and measurements from "Computer-Aided Diagnosis (CAD) and AI software." While the viewer itself might not contain AI/ML, it is designed to integrate with and display results from AI software, indicating its intended use within an AI-enabled workflow.
No.
The device is described as software for diagnostic and clinical review of medical images and does not involve any therapeutic action. Its purpose is to aid in diagnosis and image manipulation, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "OmegaAI Image Viewer is intended for diagnostic purposes (on desktorms) and as a non-diagnostic review tool (on mobile platforms)." The "Device Description" also mentions its use as a "diagnostic viewer" on desktop platforms.
Yes
The device is described as "software for diagnostic and clinical review" and is intended to be used with "off the shelf computing devices." The description focuses entirely on the software's functionalities for viewing and manipulating medical images, without mentioning any proprietary hardware components included with the device.
Based on the provided text, the OmegaAI Image Viewer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- OmegaAI Image Viewer's Intended Use: The text clearly states that the OmegaAI Image Viewer is software for viewing and manipulating medical images and videos generated from various imaging modalities (X-ray, CT, MRI, Ultrasound, etc.) and other sources like cameras and endoscopy. It is used for diagnostic and clinical review of these images.
- No Mention of Specimen Analysis: There is no mention of the OmegaAI Image Viewer being used to analyze or process biological specimens. Its focus is on the visual interpretation and manipulation of medical images.
Therefore, while the OmegaAI Image Viewer is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications 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, 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Mentions AI.
Input Imaging Modality
CR, CT, DX, MR, MG, NM, US, PET, RG, SC, VL, XA, Film Digitizer, X-ray, Computed tomography, MRI, Ultrasound, PET.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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: +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
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
6
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.
7
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.
8
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 | |||
| 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 | |||
| 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, | |||
| gastroenterology, ENT, orthopedics, | |||
| internal medicine, emergency | |||
| medicine, dermatology, dentistry, | |||
| cardiology, rheumatology, | |||
| 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 diagnostic
purposes (on desktop platforms) 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 | This software displays
medical images and
associated documents. With
appropriate display monitors,
lighting, image quality, and
level of lossy image
compression, the software is
intended for use as a primary
diagnostic and review tool for
use by trained healthcare
professionals.
Each healthcare professional
must determine if the level of
loss is acceptable for their
purpose. This software is not
suitable for primary diagnosis
of mammograms.
Caution: Federal law
restricts this device to sell
by or on the order of a
physician. | Nucleus.io is a software-
based image management
solution and PACS intended
to be used by radiologists and
other clinicians. Nucleus.io
provides image receipt,
diagnostic viewing, storage,
distribution, enhancement,
sharing, manipulation (mark
up and adjustment tools), and
networking of medical 2D/3D
images at distributed
locations. All modules of
Nucleus.io are web-based and
thus can operate completely
remote.
Nucleus.io displays both
lossless and lossy compressed
images. For lossy images, the
medical processional user
must determine if the level of
loss is acceptable for their
purposes.
Display monitors used for
reading medical images for
diagnostic purposes must
comply with applicable
regulatory approvals and
with quality control
requirements for their use
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.
9
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
©1994-2022 RamSoft Inc. All Rights Reserved
10
| 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 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
interruptions, low-memory
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. | | | Toll Free: +1 888.343.9146
Fax: +1 416.674.7147 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The OmegaAI Image Viewer is
intended for diagnostic purposes
and to be used as a review tool. | Primary diagnostic and
review tool.
This software is not suitable
for primary diagnosis of
mammograms. | Nucleus.io is intended for
diagnostic purposes and to be
used as a review tool. |
| Image
manipulation
features | Adjustment Tools:
Window level, rotate, flip, pan,
stack roll, and zoom.
Markup Tools:
Annotate, angle, cobb angle,
probe, Mark ROI, and
measurement. | Window/Level, Zoom,
Rotation, Flip, Pan,
Measure, and
Annotation.
RapidResultsdoes not
produce or alter any
images and medical
data. | Window/level, flip/rotation,
zoom, pan, measurement and
Mark ROI. |
| RamSoft, Inc. | | | ©1994-2022 RamSoft Inc. |
| HIPAA
Compliance | OmegaAI Image Viewer
connects to the PACS using
HTTPS.
OmegaAI Image Viewer does
not store images on any user's
device. Images are stored in the
PACS, not on the device.
When the web browser or
mobile application is closed, all
images and information are
gone from the device. | The Viewer secured connects
to the PACS using HTTPS
Images stay in the PACS, not
on the device. When the web
browser or mobile application
is closed, all images and
information are gone from the
device. RapidResults does not
store images on any user's
device. | Nucleus.io connects to the
PACS using HTTPS.
Images are stored in the
PACS, not on the device.
When the web browser or
mobile application is closed,
all images and information
are gone from the device.
Nucleus.io does not store
images on any user's device. |
| Support
Modalities | View all image modalities,
including CR, CT, DX, MR,
MG, NM, US, PET, RG, SC,
VL, XA, PET, and Film
Digitizer. | View all image modalities,
including X-ray, CT, MRI,
color ultrasound and X-Ray
angiography. | View all image modalities,
including CR, CT, DX, MR,
MG, NM, RF, US, and XA. |
| Architecture | Server-based software solution
that displays images and
reports from a PACS using a
zero-footprint application
(browser).
No installation is needed. | Server-based software
solution that display images
and reports from a PACS
using a zero-footprint
application (HTML5) | Server-based software
solution that displays medical
images and reports from a
site's existing
image archives (radiology,
cardiology & other PACS and
VNA systems), using a zero-
footprint application
(browser).
No installation needed. |
| Technology | Use of various technology
standards (LDAP, SSO,
HTTPS, HTML, HL-7
Integration web services, etc.) | Use of various technology
standards (LDAP, SSO,
HTTPS, HTML, HTML5,
CSS, XML, web services,
etc.) | Use of various technology
standards (LDAP, HTTPS,
HTML, HL-7 Integration web
services, etc.) |
| Support
Platforms,
Devices | Supports major desktop (for
diagnostic purposes) and
mobile platforms (for non-
diagnostic purposes; can be
used as a review tool) such as
Microsoft Edge, Chrome,
Safari, Apple iOS, Android,
Windows and Mac devices. | Support major desktop and
mobile browsers such as
Internet Explorer 10.0 or
higher, Chrome, and Safari;
on Apple iOS, Android,
Windows Mobile, and
Black Berry devices. | Supports major desktop and
mobile browsers such as
Chrome, and Safari; on Apple
iOS, Android, Windows
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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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)