FDA 510(k)

Deep Learning Image Reconstruction

Número K: K193170 · 2019-12-13

RequerenteGe Healthcare Japan Corporation

Data da decisão2019-12-13

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Deep Learning Image Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193170. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Deep Learning Image Reconstruction?

Deep Learning Image Reconstruction is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K193170.

When did Deep Learning Image Reconstruction receive FDA 510(k) clearance?

Deep Learning Image Reconstruction received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193170.

Who is the listed applicant for Deep Learning Image Reconstruction?

The FDA 510(k) record lists Ge Healthcare Japan Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deep Learning Image Reconstruction?

The FDA product code for Deep Learning Image Reconstruction is JAK.

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Outros registros que listam Ge Healthcare Japan Corporation como candidato(a)

K253686True Definition DL K233698True Enhance DL K230807Deep Learning Image Reconstruction K220961Deep Learning Image Reconstruction K213938Revolution Ascend K212067Deep Learning Image Reconstruction

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