# K122523: Carestream Vue Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Oct 23, 2012 after 64 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CARESTREAM Vue 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. The Lesion Management Application is a module that works with CARESTREAM Vue PACS for measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings. Lesion Management Application is not to be used for mammography.

Source page: https://510kreport.com/device/K122523
Methodology: https://510kreport.com/methodology