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FDA 510(k)

uMR 780

K-Number: K193176 · 2020-05-05

Decision Date2020-05-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMR 780 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-05-05 under approval number K193176. 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 780?

uMR 780 is a medical device that received FDA 510(k) clearance on 2020-05-05. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K193176.

When was uMR 780 approved by the FDA?

uMR 780 received FDA 510(k) clearance on 2020-05-05, under approval number K193176.

What company makes uMR 780?

uMR 780 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uMR 780?

The FDA product code for uMR 780 is LNH.

Other Devices by Shanghai United Imaging Healthcare Co., Ltd.

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Related Devices (Code: LNH)

Official Source

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