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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
Device Name OCTAVE SPEEDER HEAD
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received06/29/2012
Decision Date 08/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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