# K201004: Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: May 1, 2020 after 15 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). 23 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K182551: Wireless Digital Flat Panel Detector, Iray Technology Taicang, Ltd. (2018) Summary page 5.

## Most influential descendants
- K210316: Mars 1417X Wireless Digital Flat Panel Detector (2021), 3 descendants of its own
- 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
Mars1417V-TSI wireless digital flat panel detector and Mano4336W wireless digital flat panel detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are 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/K201004
Methodology: https://510kreport.com/methodology