uMR Omega
K-Number: K193200 · 2020-03-27
Decision Date2020-03-27
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 2020-03-27 under approval number K193200. 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 2020-03-27. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K193200.
When was uMR Omega approved by the FDA?
uMR Omega received FDA 510(k) clearance on 2020-03-27, under approval number K193200.
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.
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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.