# Iray Technology Taicang, Ltd.

- Location (FDA's records): Taicang, CN
- FDA decisions: 21 (2018–2023): 21 510(k) clearances
- Product codes: MQB (17), MUH (3), EHD (1)
- 510(k) review time since 2016: median 30 days, against 48 for FDA's reviews in the same codes and years (13 of 21 faster)
- Predicates its devices cite: 21 (16 its own); citations of its devices by later devices: 23 (16 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Iray Technology (Shanghai), Ltd.: 2 (https://510kreport.com/company/iray-technology-shanghai)
- Dexis, LLC: 1 (https://510kreport.com/company/dexis)
- Vieworks Co., Ltd.: 1 (https://510kreport.com/company/vieworks)
- Genoray Co., Ltd.: 1 (https://510kreport.com/company/genoray)

## Firms that cite its devices most
- Iray Imaging Technology (Haining) Limited: 3 (https://510kreport.com/company/iray-imaging-technology-haining)
- Biokinemetrics, Inc.: 2 (https://510kreport.com/company/biokinemetrics)
- Ray Imaging Technology (Haining) Limited: 1 (https://510kreport.com/company/ray-imaging-technology-haining)
- Tuxedo Imaging, LLC: 1 (https://510kreport.com/company/tuxedo-imaging)

## Its most-cited devices
- K182551: Wireless Digital Flat Panel Detector (2018), cited by 5
- K210312: PlutoX Digital Intraoral X-Ray Imaging System (2021), cited by 4
- K201043: Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) (2020), cited by 2
- K210316: Mars 1417X Wireless Digital Flat Panel Detector (2021), cited by 2
- K183713: Wireless Digital Flat Detector (2019), cited by 2
- K213529: Focus HD 43 Detector (2022), cited by 1

## Recent decisions
- K223010: Portable X-ray System (Jan 17, 2023)
- K222886: Mercu 1717V (Oct 20, 2022)
- K221714: Flat Panel Detector (Jun 29, 2022)
- K221345: Wireless Digital Flat Panel Detector (Jun 16, 2022)
- K220536: Digital flat panel detector (Apr 28, 2022)
- K220668: Wireless Digital Flat Panel Detector (Apr 1, 2022)
- K213529: Focus HD 43 Detector (Mar 29, 2022)
- K213646: Focus HD 35 Detector (Mar 29, 2022)

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