SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K112112
Device Name SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
Applicant
SENTINEL MEDICAL, INC.
555 richmond street west
suite 800
toronto, 

CA

m5v 3b1

Applicant Contact joan medley
Correspondent
SENTINEL MEDICAL, INC.
555 richmond street west
suite 800
toronto, 

CA

m5v 3b1

Correspodent Contact joan medley
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 07/25/2011
Decision Date 08/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No