# K241981: Change Healthcare Stratus Imaging PACS

- Pathway: 510(k) (Traditional)
- Applicant: Change Healthcare Canada Company
- Decided: Nov 12, 2024 after 130 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: 7 generations back to K945188 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203249: Nucleus.io, Nucleushealth, LLC (2020) Summary page 5.

## Indications for use
Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system intended to process and display medical images for the purposes of diagnostic viewing and interpretation by qualified and trained healthcare professionals, including, but not restricted to, radiologists and non-radiology physicians. The Diagnostic Viewer of Change Healthcare Stratus Imaging PACS provides medical image post-processing functions such as image manipulation and enhancement that are intended for use in the clinical image review and analysis of medical images acquired through DICOM-compliant imaging devices or IT interfaces. Change Healthcare Stratus Imaging PACS can be used as a full-featured medical image management and processing system or as an independent viewer in clinical settings. Only uncompressed or non-lossy compressed DICOM images can be used for primary image diagnosis and interpretation for mammography using monitors intended for mammography display and cleared by the regulatory authority in your region or jurisdiction. Change Healthcare Stratus Imaging PACS is not intended for diagnostic use on mobile devices.

Source page: https://510kreport.com/device/K241981
Methodology: https://510kreport.com/methodology