Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
K-Number: K161724 · 2017-04-28
ApplicantRadiomed Corporation
Decision Date2017-04-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is a medical device manufactured by Radiomed Corporation. It received FDA 510(k) clearance on 2017-04-28 under approval number K161724. 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 Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Radiomed Corporation. The 510(k) number is K161724.
When was Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) approved by the FDA?
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) received FDA 510(k) clearance on 2017-04-28, under approval number K161724.
What company makes Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is manufactured by Radiomed Corporation.
What is the FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?
The FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) 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.