# K152977: DG Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Dicom Grid, Inc.
- Decided: Jan 25, 2016 after 109 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: 6 generations back to K954678 (1996). 23 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product, Erad, Inc. (2012) Summary page 4.

## Most influential descendants
- K202335: Ambra ProViewer (2020), 2 descendants of its own
- K240839: OpenRad Cloud (2024), 0 descendants of its own
- K231360: Ambra PACS (2023), 0 descendants of its own
- K201296: i-Rapha Solution (2020), 0 descendants of its own

## Recalls of this device
- Dec 16, 2016 · Class II · Z-1045-2017: A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

## Indications for use
DG 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. DG Viewer, a component of DG PACS, displays and manages diagnostic quality DICOM images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. Not intended for diagnostic use on mobile devices.

Source page: https://510kreport.com/device/K152977
Methodology: https://510kreport.com/methodology