uMC 560i
K-Number: K183144 · 2019-12-19
Decision Date2019-12-19
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMC 560i is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under approval number K183144. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uMC 560i?
uMC 560i is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183144.
When was uMC 560i approved by the FDA?
uMC 560i received FDA 510(k) clearance on 2019-12-19, under approval number K183144.
What company makes uMC 560i?
uMC 560i is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMC 560i?
The FDA product code for uMC 560i is OWB.
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.