# K181185: Change Healthcare Enterprise Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Change Healthcare Canada Company
- Decided: Aug 29, 2018 after 118 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K954874 (1996). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161130: ResolutionMD, Calgary Scientific, Inc. (2016) Summary page 4.

## Recalls of this device
- Apr 19, 2021 · Class II · Z-1773-2021: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
- Mar 17, 2021 · Class II · Z-1508-2021: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

## Indications for use
Change Healthcare Enterprise Viewer is a software-based enterprise viewer intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Change Healthcare Enterprise Viewer is intended as well to facilitate collaboration and sharing of these materials within and outside the healthcare enterprise. Change Healthcare Enterprise Viewer is intended to enable trained healthcare professionals to perform a diagnostic review on a workstation and non-diagnostic review on a mobile device, of a patient’s medical images and to aid their clinical decision-making process. Users access the application on a desktop computer or specific mobile devices through a standard web browser. Change Healthcare Enterprise Viewer is not intended for diagnostic use on a mobile device. When used on a mobile device, Change Healthcare Enterprise Viewer is not intended to replace full workstations and should only be used when there is no access to a workstation. Change Healthcare Enterprise Viewer is not intended for primary mammography diagnosis.

Source page: https://510kreport.com/device/K181185
Methodology: https://510kreport.com/methodology