FDA 510(k)

uMR Astra

Número K: K260113 · 2026-05-22

RequerenteShanghai United Imaging Healthcare Co., Ltd.

Data da decisão2026-05-22

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

uMR Astra 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 2026-05-22 under 510(k) number K260113. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the uMR Astra?

uMR Astra is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K260113.

When did uMR Astra receive FDA 510(k) clearance?

uMR Astra received FDA 510(k) clearance on 2026-05-22, under 510(k) number K260113.

Who is the listed applicant for uMR Astra?

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 uMR Astra?

The FDA product code for uMR Astra is LNH.

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Outros registros que listam Shanghai United Imaging Healthcare Co., Ltd. como candidato(a)

K253726uAngio AVIVA CX K261427uMI Panvivo (uMI Panvivo M)K253077uOmnispace.MR K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253173uCT 780 with uWS-CT-Dual Energy Analysis

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Fonte oficial

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