FDA 510(k)

FDR AQRO (DR-XD 1000)

Número K: K170858 · 2017-04-24

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2017-04-24

Código do produtoIZL

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

FDR AQRO (DR-XD 1000) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K170858. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FDR AQRO (DR-XD 1000)?

FDR AQRO (DR-XD 1000) is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K170858.

When did FDR AQRO (DR-XD 1000) receive FDA 510(k) clearance?

FDR AQRO (DR-XD 1000) received FDA 510(k) clearance on 2017-04-24, under 510(k) number K170858.

Who is the listed applicant for FDR AQRO (DR-XD 1000)?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FDR AQRO (DR-XD 1000)?

The FDA product code for FDR AQRO (DR-XD 1000) is IZL.

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Fonte oficial

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