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FDA 510(k)

uMR 580, uMR 588

K-Number: K183137 · 2019-01-11

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2019-01-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMR 580, uMR 588 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 2019-01-11 under 510(k) number K183137. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uMR 580, uMR 588?

uMR 580, uMR 588 is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183137.

When did uMR 580, uMR 588 receive FDA 510(k) clearance?

uMR 580, uMR 588 received FDA 510(k) clearance on 2019-01-11, under 510(k) number K183137.

Who is the listed applicant for uMR 580, uMR 588?

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 580, uMR 588?

The FDA product code for uMR 580, uMR 588 is LNH.

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: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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