FDA 510(k) Application Details - K120073

Device Classification Name

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510(K) Number K120073
Device Name INFX-8000V WITH
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN, CA 92780 US
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Contact PAUL BIGGINES
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Regulation Number

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Classification Product Code OWB
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Date Received 01/10/2012
Decision Date 01/26/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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