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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 K151451
Device Name Aplio 500/400/300 Diagnostic Ultrasound System V6.0
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
1385 SHIMOISHIGAMI
OTAWARA-SHI,  JP 324-8550
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
TUSTIN,  CA  92780
Correspondent Contact ORLANDO TADEO
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/29/2015
Decision Date 07/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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