# K233572: Autofuse

- Pathway: 510(k) (Traditional)
- Applicant: Pymedix
- Decided: Mar 6, 2024 after 121 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: 10 generations back to K954874 (1996). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081076: Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response, Velocity Medical Solutions, LLC (2008) Summary page 4.

## Indications for use
Autofuse is a software package that provides physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume operation, volume rendering, registration and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, and other medical specialties. Autofuse is not intended for mammography.

Source page: https://510kreport.com/device/K233572
Methodology: https://510kreport.com/methodology