# K081168: Brit Pacs Systems

- Pathway: 510(k) (Traditional)
- Applicant: Brit Systems, Inc.
- Decided: Mar 23, 2009 after 333 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 K913770 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062477: Amicas Vision Series Pacs, Model 4.3, Amicas, Inc. (2006) Summary page 1.
- K041935: DR Systems Pacs, Release 6.1, Dr Systems, Inc. (2004) Summary page 1.

## Indications for use
The BRIT PACS Systems is an image management system whose intended use is to provide (scaleable ) DICOM compatible PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems. This -also includes the display of structured.reports and mammography images that have been created according to DICOM "For Presentationes and will include standard features and other Mammo tools. Lossy compressed mammograpfiy images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.

Source page: https://510kreport.com/device/K081168
Methodology: https://510kreport.com/methodology