# K212528: Change Healthcare Cardiology

- Pathway: 510(k) (Traditional)
- Applicant: Change Healthcare Israel, Ltd.
- Decided: Oct 18, 2021 after 68 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: 9 generations back to K842308 (1984). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181080: McKesson Cardiology, Change Healthcare Israel, Ltd. (2018) Summary page 4.

## Indications for use
Change Healthcare Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources. Change Healthcare Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration. Change Healthcare Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting. Change Healthcare Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.

Source page: https://510kreport.com/device/K212528
Methodology: https://510kreport.com/methodology