uMR Omega
K-Number: K243122 · 2025-05-21
Decision Date2025-05-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR Omega is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under approval number K243122. 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?
uMR Omega is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243122.
When was uMR Omega approved by the FDA?
uMR Omega received FDA 510(k) clearance on 2025-05-21, under approval number K243122.
What company makes uMR Omega?
uMR Omega is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR Omega?
The FDA product code for uMR Omega is LNH.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Related Devices (Code: LNH)
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.
K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.
K162403HyperBandGe Medical Systems, LLC
K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
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.