FDA 510(k)

Lux HD 2530 detector (Lux HD 2530)

Número K: K252911 · 2025-10-09

RequerenteIray Imaging Technology (Haining) Limited

Data da decisão2025-10-09

Código do produtoMQB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lux HD 2530 detector (Lux HD 2530) 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 2025-10-09 under 510(k) number K252911. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lux HD 2530 detector (Lux HD 2530)?

Lux HD 2530 detector (Lux HD 2530) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Iray Imaging Technology (Haining) Limited. The 510(k) number is K252911.

When did Lux HD 2530 detector (Lux HD 2530) receive FDA 510(k) clearance?

Lux HD 2530 detector (Lux HD 2530) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252911.

Who is the listed applicant for Lux HD 2530 detector (Lux HD 2530)?

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 Lux HD 2530 detector (Lux HD 2530)?

The FDA product code for Lux HD 2530 detector (Lux HD 2530) is MQB.

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

K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)K230998Digital Wireless Intraoral X-Ray Sensor K230811Digital Intraoral X-Ray Sensor

Dispositivos Relacionados (Código: MQB)

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited

Fonte oficial

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