# K090062: WV1417A Digital X-Ray Direct Imaging Flat Panel Detector System

- Pathway: 510(k) (Traditional)
- Applicant: Direct Digital Imaging Technology (Beijing), Inc.
- Decided: May 18, 2009 after 129 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The WV1417A Digital X-ray Direct imaging Flat Panel Detector System provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

Source page: https://510kreport.com/device/K090062
Methodology: https://510kreport.com/methodology