uWS-MR
K-Number: K183164 · 2019-03-22
Decision Date2019-03-22
Product CodeLLZ
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 2019-03-22 under approval number K183164. The device is classified under product code LLZ. 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 2019-03-22. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183164.
When was uWS-MR approved by the FDA?
uWS-MR received FDA 510(k) clearance on 2019-03-22, under approval number K183164.
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 LLZ.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Related Devices (Code: LLZ)
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.