uOmniscan
K-Number: K243666 · 2025-06-17
Decision Date2025-06-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uOmniscan is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-06-17 under approval number K243666. 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 uOmniscan?
uOmniscan is a medical device that received FDA 510(k) clearance on 2025-06-17. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243666.
When was uOmniscan approved by the FDA?
uOmniscan received FDA 510(k) clearance on 2025-06-17, under approval number K243666.
What company makes uOmniscan?
uOmniscan is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uOmniscan?
The FDA product code for uOmniscan 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.