# K170480: Models 3543A, 4343A, 2929A and A843B

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai PZ Medical Technolgoy Co., Ltd.
- Decided: Jul 7, 2017 after 141 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: 11 generations back to K981556 (1998). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152151: ATAL 9, Atlaim Corporation (2015) Summary page 4.
- K161730: Wireless Digital Flat Panel Detector, Iray Technology (Shanghai), Ltd. (2016) Summary page 4.
- K153058: CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors, Careray Digital Medical System Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K212105: 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF (2021), 0 descendants of its own

## Indications for use
Model#'s 3543A, 4343A, 2929A and A843B; Solid State X-ray Imager (Flat Panel/Digital Imager) are indicated for use in generating radiographic images of human anatomy. They are intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, angiographic, and mammographic applications. As prescribed by a licensed physician

Source page: https://510kreport.com/device/K170480
Methodology: https://510kreport.com/methodology