VIVIX-M
K-Number: K241113 · 2025-01-16
ApplicantVieworks Co., Ltd.
Decision Date2025-01-16
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
VIVIX-M is a medical device manufactured by Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2025-01-16 under approval number K241113. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VIVIX-M?
VIVIX-M is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Vieworks Co., Ltd.. The 510(k) number is K241113.
When was VIVIX-M approved by the FDA?
VIVIX-M received FDA 510(k) clearance on 2025-01-16, under approval number K241113.
What company makes VIVIX-M?
VIVIX-M is manufactured by Vieworks Co., Ltd..
What is the FDA product code for VIVIX-M?
The FDA product code for VIVIX-M is MUE.
Other Devices by Vieworks Co., Ltd.
Related Devices (Code: MUE)
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.