# K213529: Focus HD 43 Detector

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Mar 29, 2022 after 145 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: 15 generations back to K981556 (1998). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210314: Mars1717X Wireless Digital Flat Panel Detector, Iray Technology Taicang, Ltd. (2021) Summary page 5.

## Most influential descendants
- K243556: Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (2025), 2 descendants 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
- K252911: Lux HD 2530 detector (Lux HD 2530) (2025), 0 descendants of its own

## Indications for use
Focus HD 43 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/K213529
Methodology: https://510kreport.com/methodology