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FDA 510(k)

uPMR 790

K-Number: K222540 · 2022-11-14

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2022-11-14
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uPMR 790 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 2022-11-14 under 510(k) number K222540. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uPMR 790?

uPMR 790 is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K222540.

When did uPMR 790 receive FDA 510(k) clearance?

uPMR 790 received FDA 510(k) clearance on 2022-11-14, under 510(k) number K222540.

Who is the listed applicant for uPMR 790?

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 uPMR 790?

The FDA product code for uPMR 790 is OUO.

Other records listing Shanghai United Imaging Healthcare Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261427uMI Panvivo (uMI Panvivo M)K260113uMR AstraK253077uOmnispace.MRK260524uMI 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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Related Devices (Code: OUO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253963Cubresa BrainPETCubresa, Inc.K253023BIOGRAPH OneSiemens Healthineers AGK234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA PET/MRGe Medical Systems, LLCK200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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