FDA 510(k)

Wireless/ Wired X-Ray Flat Panel Detectors

Número K: K243734 · 2025-04-18

RequerenteAllengers Medical Systems Limited

Data da decisão2025-04-18

Código do produtoMQB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wireless/ Wired X-Ray Flat Panel Detectors is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K243734. 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 Wireless/ Wired X-Ray Flat Panel Detectors?

Wireless/ Wired X-Ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K243734.

When did Wireless/ Wired X-Ray Flat Panel Detectors receive FDA 510(k) clearance?

Wireless/ Wired X-Ray Flat Panel Detectors received FDA 510(k) clearance on 2025-04-18, under 510(k) number K243734.

Who is the listed applicant for Wireless/ Wired X-Ray Flat Panel Detectors?

The FDA 510(k) record lists Allengers Medical Systems Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors?

The FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors is MQB.

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Outros registros que listam Allengers Medical Systems Limited como candidato(a)

K253296Digital C-ARM with 3D K223009Wireless/Wired X-Ray Flat Panel Detectors K223060DigiX FDX K220311Cardiovascular Angiography System K200218Digiscan FDX K192541DigiX FDX

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: MQB)

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Fonte oficial

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