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FDA 510(k)

Digital Intraoral X-Ray Sensor

K-Number: K230811 · 2023-04-21

ApplicantIray Imaging Technology (Haining) Limited
Decision Date2023-04-21
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Digital Intraoral X-Ray Sensor is a medical device manufactured by Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2023-04-21 under approval number K230811. 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 Intraoral X-Ray Sensor?

Digital Intraoral X-Ray Sensor is a medical device that received FDA 510(k) clearance on 2023-04-21. It is manufactured by Iray Imaging Technology (Haining) Limited. The 510(k) number is K230811.

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

Digital Intraoral X-Ray Sensor received FDA 510(k) clearance on 2023-04-21, under approval number K230811.

What company makes Digital Intraoral X-Ray Sensor?

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

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

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

Related Clinical Trials

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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

K230998Digital Wireless 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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