FDA 510(k)

Medical Image Post-processing Software (uOmnispace.CT)

Número K: K242624 · 2025-05-14

RequerenteShanghai United Imaging Healthcare Co., Ltd.

Data da decisão2025-05-14

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Image Post-processing Software (uOmnispace.CT) 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 2025-05-14 under 510(k) number K242624. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medical Image Post-processing Software (uOmnispace.CT)?

Medical Image Post-processing Software (uOmnispace.CT) is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K242624.

When did Medical Image Post-processing Software (uOmnispace.CT) receive FDA 510(k) clearance?

Medical Image Post-processing Software (uOmnispace.CT) received FDA 510(k) clearance on 2025-05-14, under 510(k) number K242624.

Who is the listed applicant for Medical Image Post-processing Software (uOmnispace.CT)?

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 Medical Image Post-processing Software (uOmnispace.CT)?

The FDA product code for Medical Image Post-processing Software (uOmnispace.CT) is QIH.

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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)K260113uMR Astra 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)

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