uOmnispace
K-Number: K230039 · 2023-07-20
Decision Date2023-07-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uOmnispace is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under approval number K230039. 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 uOmnispace?
uOmnispace is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K230039.
When was uOmnispace approved by the FDA?
uOmnispace received FDA 510(k) clearance on 2023-07-20, under approval number K230039.
What company makes uOmnispace?
uOmnispace is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uOmnispace?
The FDA product code for uOmnispace 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.