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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 K163702
Device Name Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
1385 SHIMOISHIGAMI
OTAWARA-SHI,  JP 324-8550
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS INC
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Correspondent Contact ORLANDO TADEO JR.
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/29/2016
Decision Date 05/30/2017
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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