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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 the device name listed in this FDA 510(k) record. The listed applicant is Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2023-04-21 under 510(k) 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. The listed applicant is Iray Imaging Technology (Haining) Limited. The 510(k) number is K230811.

When did Digital Intraoral X-Ray Sensor receive FDA 510(k) clearance?

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

Who is the listed applicant for Digital Intraoral X-Ray Sensor?

The FDA 510(k) record lists Iray Imaging Technology (Haining) Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Iray Imaging Technology (Haining) Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252911Lux HD 2530 detector (Lux HD 2530)K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)K230998Digital Wireless Intraoral X-Ray Sensor

Related Devices (Code: MUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

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

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