OASIS MRI System

System, Nuclear Magnetic Resonance Imaging

Hitachi Healthcare Americas

The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Oasis Mri System.

Pre-market Notification Details

Device IDK202030
510k NumberK202030
Device Name:OASIS MRI System
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg,  OH  44087
ContactAaron Pierce
CorrespondentAaron Pierce
Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg,  OH  44087
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-22
Decision Date2020-10-21

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