uMR Ultra
K-Number: K243547 · 2025-07-17
Decision Date2025-07-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR Ultra is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-07-17 under approval number K243547. 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 Ultra?
uMR Ultra is a medical device that received FDA 510(k) clearance on 2025-07-17. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243547.
When was uMR Ultra approved by the FDA?
uMR Ultra received FDA 510(k) clearance on 2025-07-17, under approval number K243547.
What company makes uMR Ultra?
uMR Ultra is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR Ultra?
The FDA product code for uMR Ultra 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.