uMR 680
K-Number: K243397 · 2025-07-16
Decision Date2025-07-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR 680 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-07-16 under approval number K243397. 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 2025-07-16. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243397.
When was uMR 680 approved by the FDA?
uMR 680 received FDA 510(k) clearance on 2025-07-16, under approval number K243397.
What company makes uMR 680?
uMR 680 is manufactured by Shanghai United Imaging Healthcare 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.