uMR Jupiter
K-Number: K250246 · 2025-08-05
Decision Date2025-08-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR Jupiter is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-08-05 under approval number K250246. 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 Jupiter?
uMR Jupiter is a medical device that received FDA 510(k) clearance on 2025-08-05. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K250246.
When was uMR Jupiter approved by the FDA?
uMR Jupiter received FDA 510(k) clearance on 2025-08-05, under approval number K250246.
What company makes uMR Jupiter?
uMR Jupiter is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR Jupiter?
The FDA product code for uMR Jupiter 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.