R2-MRI ANALYSIS SYSTEM

System, Nuclear Magnetic Resonance Imaging

INNER VISION BIOMETRICS PTY LTD

The following data is part of a premarket notification filed by Inner Vision Biometrics Pty Ltd with the FDA for R2-mri Analysis System.

Pre-market Notification Details

Device IDK043271
510k NumberK043271
Device Name:R2-MRI ANALYSIS SYSTEM
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant INNER VISION BIOMETRICS PTY LTD 216 STIRLING HWY Claremont, Perth,  AU 6010
ContactJanet Preuss
CorrespondentJanet Preuss
INNER VISION BIOMETRICS PTY LTD 216 STIRLING HWY Claremont, Perth,  AU 6010
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-26
Decision Date2005-01-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09355529000002 K043271 000

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