# K151774: CARESTREAM Vue Motion

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Sep 21, 2015 after 82 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K842308 (1984). 29 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132824: Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application, Carestream Health, Inc. (2014) Summary page 4.
- K133534: Mckesson Cardiology Ecg Mobile, Mckesson Israel, Ltd. (2014) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1692-2026: Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

## Indications for use
The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full 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 FDA for mammography.

Source page: https://510kreport.com/device/K151774
Methodology: https://510kreport.com/methodology