# K231360: Ambra PACS

- Pathway: 510(k) (Special)
- Applicant: Dicom Grid Dba Ambra Health
- Decided: Jun 7, 2023 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K942120 (1994). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202335: Ambra ProViewer, Dicom Grid Inc Dba Ambra Health (2020) Summary page 5.

## Recalls of this device
- Nov 18, 2025 · Class II · Z-0941-2026: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar

## Indications for use
Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to Patient image, demographic and report information. Ambra Pro Viewer, a component of Ambra PACS, displays, modifies and manages diagnostic quality DICOM images including 3D visualization and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography Display. Not intended for diagnostic use on mobile devices.

Source page: https://510kreport.com/device/K231360
Methodology: https://510kreport.com/methodology