# K083673: Carestream Pacs, Model Carestream Pacs Vii

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Dec 30, 2008 after 19 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: 4 generations back to K954678 (1996). 7 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002) Summary page 1.

## Most influential descendants
- K110919: Carestream Pacs (2011), 8 descendants of its own
- K132824: Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application (2014), 6 descendants of its own
- K151774: CARESTREAM Vue Motion (2015), 4 descendants of its own
- K170434: Enterprise Imaging XERO Viewer 8.1 (2017), 3 descendants of its own
- K100094: Carestream Image Suite (2010), 2 descendants of its own

## Indications for use
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

Source page: https://510kreport.com/device/K083673
Methodology: https://510kreport.com/methodology