VenusX
K-Number: K232489 · 2024-04-12
ApplicantLinatech, LLC
Decision Date2024-04-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
VenusX is a medical device manufactured by Linatech, LLC. It received FDA 510(k) clearance on 2024-04-12 under approval number K232489. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VenusX?
VenusX is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Linatech, LLC. The 510(k) number is K232489.
When was VenusX approved by the FDA?
VenusX received FDA 510(k) clearance on 2024-04-12, under approval number K232489.
What company makes VenusX?
VenusX is manufactured by Linatech, LLC.
What is the FDA product code for VenusX?
The FDA product code for VenusX is IYE.
Related Devices (Code: IYE)
K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc.
K161400ImagingRing SystemMedphoton GmbH
K162468ClearCheckRadformation
K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV
K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC
K162265CushionCast Moldable CushionsIzi Medical Products, LLC
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.