uMR570
K-Number: K201540 · 2020-07-06
Decision Date2020-07-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR570 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-07-06 under approval number K201540. 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 uMR570?
uMR570 is a medical device that received FDA 510(k) clearance on 2020-07-06. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K201540.
When was uMR570 approved by the FDA?
uMR570 received FDA 510(k) clearance on 2020-07-06, under approval number K201540.
What company makes uMR570?
uMR570 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR570?
The FDA product code for uMR570 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.