# Iray Imaging Technology (Haining) Limited

- Location (FDA's records): Haining, CN
- FDA decisions: 4 (2023–2025): 4 510(k) clearances
- Product codes: MUH (2), MQB (2)
- 510(k) review time since 2016: median 74 days, against 92 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Iray Technology Taicang, Ltd.: 3 (https://510kreport.com/company/iray-technology-taicang)

## Firms that cite its devices most
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)

## Its most-cited devices
- K243556: Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (2025), cited by 2

## Recent decisions
- K252911: Lux HD 2530 detector (Lux HD 2530) (Oct 9, 2025)
- K243556: Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (Mar 18, 2025)
- K230998: Digital Wireless Intraoral X-Ray Sensor (Oct 20, 2023)
- K230811: Digital Intraoral X-Ray Sensor (Apr 21, 2023)

Source page: https://510kreport.com/company/iray-imaging-technology-haining