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FDA 510(k)

Digital Wireless Intraoral X-Ray Sensor

K-Number: K230998 · 2023-10-20

ApplicantIray Imaging Technology (Haining) Limited
Decision Date2023-10-20
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Digital Wireless Intraoral X-Ray Sensor is a medical device manufactured by Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2023-10-20 under approval number K230998. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Wireless Intraoral X-Ray Sensor?

Digital Wireless Intraoral X-Ray Sensor is a medical device that received FDA 510(k) clearance on 2023-10-20. It is manufactured by Iray Imaging Technology (Haining) Limited. The 510(k) number is K230998.

When was Digital Wireless Intraoral X-Ray Sensor approved by the FDA?

Digital Wireless Intraoral X-Ray Sensor received FDA 510(k) clearance on 2023-10-20, under approval number K230998.

What company makes Digital Wireless Intraoral X-Ray Sensor?

Digital Wireless Intraoral X-Ray Sensor is manufactured by Iray Imaging Technology (Haining) Limited.

What is the FDA product code for Digital Wireless Intraoral X-Ray Sensor?

The FDA product code for Digital Wireless Intraoral X-Ray Sensor is MUH.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT06938412 Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED

Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by Iray Imaging Technology (Haining) Limited

K230811Digital Intraoral X-Ray Sensor K252911Lux HD 2530 detector (Lux HD 2530) K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)

Related Devices (Code: MUH)

K162619I View and Imagen SensorTrident S.R.L K162585SuniIQ Digital Radiography SystemSuni Medical Imaging, Inc. K161131FONA Pan/CephFona S.R.L K160788RIOScan (RPS500)Ray Co., Ltd. K160386ReadeR, VieweR, QuickScan PSPTrident S.R.L K153144TIO-H DIGITAL RADIOGRAPHY SENSORDenttio, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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