# K081752: Edge Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Ashva Technologies, Pvt., Ltd.
- Decided: Aug 6, 2008 after 47 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: 5 generations back to K010259 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062062: Voyager Pacs System, Voyager Imaging (2006) Summary page 1.

## Indications for use
Edge PACSTM is a software device (server, web viewer, & workstation) used for diagnostic viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. Edge PACSTm can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K081752
Methodology: https://510kreport.com/methodology