FDA 510(k)

Digital Wireless Intraoral X-Ray Sensor

Número K: K230998 · 2023-10-20

RequerenteIray Imaging Technology (Haining) Limited

Data da decisão2023-10-20

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Wireless 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 2023-10-20 under 510(k) number K230998. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Iray Imaging Technology (Haining) Limited. The 510(k) number is K230998.

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

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

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

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

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Outros registros que listam Iray Imaging Technology (Haining) Limited como candidato(a)

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

Dispositivos Relacionados (Código: MUH)

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.

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