MRopen 0.5 T
K-Number: K190524 · 2019-07-01
ApplicantAsg Superconductors S.P.A.
Decision Date2019-07-01
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MRopen 0.5 T is a medical device manufactured by Asg Superconductors S.P.A.. It received FDA 510(k) clearance on 2019-07-01 under approval number K190524. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MRopen 0.5 T?
MRopen 0.5 T is a medical device that received FDA 510(k) clearance on 2019-07-01. It is manufactured by Asg Superconductors S.P.A.. The 510(k) number is K190524.
When was MRopen 0.5 T approved by the FDA?
MRopen 0.5 T received FDA 510(k) clearance on 2019-07-01, under approval number K190524.
What company makes MRopen 0.5 T?
MRopen 0.5 T is manufactured by Asg Superconductors S.P.A..
What is the FDA product code for MRopen 0.5 T?
The FDA product code for MRopen 0.5 T is LNH.
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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.