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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K121911
Model MJAS-167A
Device Name OCTAVE SPEEDER SPINE
Original Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 michelle dr
tustin,  CA  92780
Original Contact paul biggins
Regulation Number892.1000
Classification Product Code
MOS  
Date Received06/29/2012
Decision Date 08/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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