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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 K121577
Device Name APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Applicant Contact CHARLEMAGNE CHUA
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Correspondent Contact CHARLEMAGNE CHUA
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/30/2012
Decision Date 06/22/2012
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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