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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 K121910
Model MJAH-167A
Device Name OCTAVE SPEEDER HEAD
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 michelle dr
tustin,  CA  92780
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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