# K222476: OmegaAI Image Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Ramsoft, Inc.
- Decided: Nov 17, 2022 after 93 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K942120 (1994). 25 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203249: Nucleus.io, Nucleushealth, LLC (2020) Summary page 6.
- K141881: Rapidresults, Ramsoft, Inc. (2014) Summary page 6.

## Most influential descendants
- K254237: Cci Pacs Viewer (Pacs-US-001) (2026), 0 descendants of its own
- K241546: aiCockpit AI Viewer (2025), 0 descendants of its own
- K242362: Lightning Viewer (2024), 0 descendants of its own

## 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, 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 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 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.

Source page: https://510kreport.com/device/K222476
Methodology: https://510kreport.com/methodology