uMR 560
K-Number: K180926 · 2018-06-06
Decision Date2018-06-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR 560 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-06-06 under approval number K180926. 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 560?
uMR 560 is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K180926.
When was uMR 560 approved by the FDA?
uMR 560 received FDA 510(k) clearance on 2018-06-06, under approval number K180926.
What company makes uMR 560?
uMR 560 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR 560?
The FDA product code for uMR 560 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.