uWS-MR
K-Number: K192601 · 2020-06-01
Decision Date2020-06-01
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uWS-MR is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-06-01 under approval number K192601. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uWS-MR?
uWS-MR is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K192601.
When was uWS-MR approved by the FDA?
uWS-MR received FDA 510(k) clearance on 2020-06-01, under approval number K192601.
What company makes uWS-MR?
uWS-MR is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uWS-MR?
The FDA product code for uWS-MR is QIH.
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.