# K210316: Mars 1417X Wireless Digital Flat Panel Detector

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Mar 3, 2021 after 28 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: 13 generations back to K981556 (1998). 24 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201004: Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W, Iray Technology Taicang, Ltd. (2020) Summary page 5.
- (no number) Mano4336W Wireless Digital Flat Panel Detector: named in the summary without a submission number

## Most influential descendants
- K220668: Wireless Digital Flat Panel Detector (2022), 1 descendant of its own
- K221345: Wireless Digital Flat Panel Detector (2022), 0 descendants of its own
- K213646: Focus HD 35 Detector (2022), 0 descendants of its own

## Indications for use
Mars1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

Source page: https://510kreport.com/device/K210316
Methodology: https://510kreport.com/methodology