# K182550: Wireless Digital Flat Panel Detector

- Pathway: 510(k) (Traditional)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Oct 17, 2018 after 30 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K981556 (1998). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161730: Wireless Digital Flat Panel Detector, Iray Technology (Shanghai), Ltd. (2016) Summary page 5.

## Most influential descendants
- K183422: Wireless Digital Flat Panel Detector (2019), 0 descendants of its own

## Recalls of this device
- May 5, 2020 · Class II · Z-2215-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- May 5, 2020 · Class II · Z-2213-2020: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

## Indications for use
Mars1417XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.

Source page: https://510kreport.com/device/K182550
Methodology: https://510kreport.com/methodology