Search Results
Found 1 results
510(k) Data Aggregation
K Number
K043271Device Name
R2-MRI ANALYSIS SYSTEM
Manufacturer
INNER VISION BIOMETRICS PTY LTD
Date Cleared
2005-01-21
(56 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
INNER VISION BIOMETRICS PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The R2-MRI Analysis System is an accessory diagnostic device to International for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.
Device Description
Software tool used as an accessory to an MR scanning machine, to facilitate the import and visualization of data sets encompassing the multi-slice, spin-echo MRI independent of the MRI equipment vendor, to provide objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status.
Ask a Question
Page 1 of 1