# K241546: aiCockpit AI Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Fovia, Inc.
- Decided: Feb 26, 2025 after 271 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: 10 generations back to K942120 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222476: OmegaAI Image Viewer, Ramsoft, Inc. (2022) Summary page 5.

## Indications for use
Al Viewer is software for clinical review intended for use in General Radiology and other healthcare imaging applications. Al Viewer is intended to be used with off the shelf computing devices. Al Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari. Al Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Al software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Al Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images.

Source page: https://510kreport.com/device/K241546
Methodology: https://510kreport.com/methodology