uMR 570
K-Number: K230758 · 2023-05-18
Decision Date2023-05-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR 570 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-05-18 under approval number K230758. 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 570?
uMR 570 is a medical device that received FDA 510(k) clearance on 2023-05-18. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K230758.
When was uMR 570 approved by the FDA?
uMR 570 received FDA 510(k) clearance on 2023-05-18, under approval number K230758.
What company makes uMR 570?
uMR 570 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR 570?
The FDA product code for uMR 570 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.