# K212105: 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF

- Pathway: 510(k) (Traditional)
- Applicant: Pzmedical Technology Co., Ltd.
- Decided: Aug 23, 2021 after 48 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: 12 generations back to K981556 (1998). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170480: Models 3543A, 4343A, 2929A and A843B, Shanghai PZ Medical Technolgoy Co., Ltd. (2017) Summary page 4.

## Indications for use
Solid State X-ray Imager (Flat Panel/Digital Imager) Indicated for use in generating radiographic images of human anatomy. Intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, angiographic, and mammographic applications.

Source page: https://510kreport.com/device/K212105
Methodology: https://510kreport.com/methodology