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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K123992
Device Name APLIO 500/400/300 V3.0
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Applicant Contact CHARLEMAGNE CHUA
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Correspondent Contact CHARLEMAGNE CHUA
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/26/2012
Decision Date 02/06/2013
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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