# K132824: Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Feb 6, 2014 after 150 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: 6 generations back to K954678 (1996). 9 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110919: Carestream Pacs, Carestream Health, Inc. (2011)

## Most influential descendants
- K151774: CARESTREAM Vue Motion (2015), 4 descendants of its own
- K170434: Enterprise Imaging XERO Viewer 8.1 (2017), 3 descendants of its own
- K200822: Braid (2020), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own
- K231385: Rology Teleradiology Platform (v.1.22.1103) (2023), 0 descendants of its own

## Indications for use
The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable 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 review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. The Wue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, and medical images for diagnosis from different modalities including CR, DR, C, MR, NM and US. Vue Motion provides wireless and portable access to mnedical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace ful workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography.

Source page: https://510kreport.com/device/K132824
Methodology: https://510kreport.com/methodology