uMR 790
K-Number: K181371 · 2018-10-03
Decision Date2018-10-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR 790 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-10-03 under approval number K181371. 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 790?
uMR 790 is a medical device that received FDA 510(k) clearance on 2018-10-03. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K181371.
When was uMR 790 approved by the FDA?
uMR 790 received FDA 510(k) clearance on 2018-10-03, under approval number K181371.
What company makes uMR 790?
uMR 790 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR 790?
The FDA product code for uMR 790 is LNH.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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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.