uMI Panvivo
K-Number: K241596 · 2024-08-15
Decision Date2024-08-15
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMI Panvivo is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under approval number K241596. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uMI Panvivo?
uMI Panvivo is a medical device that received FDA 510(k) clearance on 2024-08-15. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K241596.
When was uMI Panvivo approved by the FDA?
uMI Panvivo received FDA 510(k) clearance on 2024-08-15, under approval number K241596.
What company makes uMI Panvivo?
uMI Panvivo is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMI Panvivo?
The FDA product code for uMI Panvivo is KPS.
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.