MapRT
K-Number: K243301 · 2025-05-19
ApplicantVision Rt, Ltd.
Decision Date2025-05-19
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MapRT is a medical device manufactured by Vision Rt, Ltd.. It received FDA 510(k) clearance on 2025-05-19 under approval number K243301. 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 MapRT?
MapRT is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Vision Rt, Ltd.. The 510(k) number is K243301.
When was MapRT approved by the FDA?
MapRT received FDA 510(k) clearance on 2025-05-19, under approval number K243301.
What company makes MapRT?
MapRT is manufactured by Vision Rt, Ltd..
What is the FDA product code for MapRT?
The FDA product code for MapRT is IYE.
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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.