uMR Omega with uWS-MR-MRS
K-Number: K220332 · 2022-10-27
Decision Date2022-10-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR Omega with uWS-MR-MRS is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-10-27 under approval number K220332. 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 Omega with uWS-MR-MRS?
uMR Omega with uWS-MR-MRS is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K220332.
When was uMR Omega with uWS-MR-MRS approved by the FDA?
uMR Omega with uWS-MR-MRS received FDA 510(k) clearance on 2022-10-27, under approval number K220332.
What company makes uMR Omega with uWS-MR-MRS?
uMR Omega with uWS-MR-MRS is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR Omega with uWS-MR-MRS?
The FDA product code for uMR Omega with uWS-MR-MRS 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.