# K202235: ArtPIX DRF

- Pathway: 510(k) (Special)
- Applicant: Cmt Medical Technologies, Ltd.
- Decided: Sep 3, 2020 after 27 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K801623 (1980). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103038: Duet DRF, Cmt Medical Technologies, Ltd. (2011) Summary page 4.

## Indications for use
The ArtPIX DRF is a digital image acquisition system to be used with integrated solid state detector, during radiography or fluoroscopy x-ray examination, to capture digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use.

Source page: https://510kreport.com/device/K202235
Methodology: https://510kreport.com/methodology