# K201172: CFP-3131, CFP-2222

- Pathway: 510(k) (Traditional)
- Applicant: Mx Imaging, Inc.
- Decided: May 29, 2020 after 28 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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 K912470 (1991). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171755: CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System, Omega Medical Imaging, LLC (2018) Summary page 4.

## Indications for use
Intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

Source page: https://510kreport.com/device/K201172
Methodology: https://510kreport.com/methodology