FDA 510(k)

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

Número K: K243617 · 2025-05-16

RequerenteShanghai United Imaging Healthcare Co., Ltd.

Data da decisão2025-05-16

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243617. 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 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis?

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243617.

When did uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis receive FDA 510(k) clearance?

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243617.

Who is the listed applicant for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis?

The FDA 510(k) record lists Shanghai United Imaging Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis?

The FDA product code for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis is JAK.

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