K-number	K220332
Device name	uMR Omega with uWS-MR-MRS
Applicant	Shanghai United Imaging Healthcare Co., Ltd.
Product code	LNH
Device class	Class II
Decision date	Oct 27, 2022
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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uMR Omega with uWS-MR-MRS

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