uMR 680
K-Number: K222755 · 2023-02-16
Decision Date2023-02-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR 680 is a medical device manufactured by Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under approval number K222755. 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 680?
uMR 680 is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K222755.
When was uMR 680 approved by the FDA?
uMR 680 received FDA 510(k) clearance on 2023-02-16, under approval number K222755.
What company makes uMR 680?
uMR 680 is manufactured by Shanghai United Imaging Intelligence Co., Ltd..
What is the FDA product code for uMR 680?
The FDA product code for uMR 680 is LNH.
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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.