# K211108: Prudent 1717, Prudent 1417, Prudent 1212

- Pathway: 510(k) (Traditional)
- Applicant: Pixxgen Corporation
- Decided: Jun 4, 2021 after 51 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K063710 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182533: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels, Pixxgen Corporation (2018) Summary page 4.

## Indications for use
Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

Source page: https://510kreport.com/device/K211108
Methodology: https://510kreport.com/methodology