uWS-MI
K-Number: K172998 · 2018-04-05
Decision Date2018-04-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uWS-MI is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-04-05 under approval number K172998. 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-MI?
uWS-MI is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K172998.
When was uWS-MI approved by the FDA?
uWS-MI received FDA 510(k) clearance on 2018-04-05, under approval number K172998.
What company makes uWS-MI?
uWS-MI is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uWS-MI?
The FDA product code for uWS-MI 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.