# K201043: Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: May 12, 2020 after 22 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.
7 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183713: Wireless Digital Flat Detector, Iray Technology Taicang, Ltd. (2019) Summary page 6.

## Most influential descendants
- K210314: Mars1717X Wireless Digital Flat Panel Detector (2021), 4 descendants of its own
- K213529: Focus HD 43 Detector (2022), 3 descendants of its own
- K243556: Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (2025), 2 descendants of its own
- K221714: Flat Panel Detector (2022), 1 descendant of its own
- K250954: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (2026), 0 descendants of its own

## Indications for use
Wireless Digital Flat Panel Detector (Model:Mars1717V-VSI, Mano4343W) 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. These two devices are not intended for mammography, dental applications. There are no differences between the 2 models except the model name and label.

Source page: https://510kreport.com/device/K201043
Methodology: https://510kreport.com/methodology