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510(k) Data Aggregation
K Number
K031536Device Name
BRAIN COIL, MODEL 9900GE-64
Manufacturer
Date Cleared
2003-07-18
(63 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL MR SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.
Device Description
Brain Coil, Model # 9900GE-64
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