OASIS MRI System
K-Number: K202030 · 2020-10-21
ApplicantHitachi Healthcare Americas
Decision Date2020-10-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OASIS MRI System is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2020-10-21 under approval number K202030. 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 OASIS MRI System?
OASIS MRI System is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K202030.
When was OASIS MRI System approved by the FDA?
OASIS MRI System received FDA 510(k) clearance on 2020-10-21, under approval number K202030.
What company makes OASIS MRI System?
OASIS MRI System is manufactured by Hitachi Healthcare Americas.
What is the FDA product code for OASIS MRI System?
The FDA product code for OASIS MRI System 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.