# K202335: Ambra ProViewer

- Pathway: 510(k) (Traditional)
- Applicant: Dicom Grid Inc Dba Ambra Health
- Decided: Sep 4, 2020 after 18 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: 8 generations back to K942120 (1994). 28 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152977: DG Pacs, Dicom Grid, Inc. (2016) Summary page 4.
- K101342: Osirix MD, Pixmeo Sarl (2010) Summary page 4.

## Most influential descendants
- K240839: OpenRad Cloud (2024), 0 descendants of its own
- K231360: Ambra PACS (2023), 0 descendants of its own

## Recalls of this device
- Jun 23, 2022 · Class II · Z-1818-2022: A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.

## 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 ProViewer, 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/K202335
Methodology: https://510kreport.com/methodology