SV BRAIN ARRAY, SIEMENS 3T

Coil, Magnetic Resonance, Specialty

MRI INTERVENTIONS, INC.

The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Sv Brain Array, Siemens 3t.

Pre-market Notification Details

Device IDK111802
510k NumberK111802
Device Name:SV BRAIN ARRAY, SIEMENS 3T
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MRI INTERVENTIONS, INC. 5 MUSICK Irvine,  CA  92618
ContactE.f. Waddell
CorrespondentE.f. Waddell
MRI INTERVENTIONS, INC. 5 MUSICK Irvine,  CA  92618
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-27
Decision Date2011-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850359007057 K111802 000
08503590070573 K111802 000
00850359007577 K111802 000

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