# K210719: Change Healthcare Anatomical AI

- Pathway: 510(k) (Traditional)
- Applicant: Change Healthcare Canada Company
- Decided: Jul 20, 2021 after 132 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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 K913770 (1991). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 5.

## Indications for use
Change Healthcare Anatomical AI is intended to analyze pixel data from CT or MR images to create comprehensive anatomic descriptors for export to integrated healthcare systems. This supplements traditional methods used for the selection, presentation or analysis of image based medical data. The application is intended to enable physicians, or other healthcare providers as well as integrated healthcare systems to rapidly identify images, series, and/ or studies of interest. Change Healthcare Anatomical AI is not indicated for patients under the age of 18 years old.

Source page: https://510kreport.com/device/K210719
Methodology: https://510kreport.com/methodology