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 IDK211406
510k NumberK211406
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
FUJIFILM Healthcare Americas Corporation 1959 Summit Commerce Park Twinsburg,  OH  44087
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-06
Decision Date2021-10-07

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.