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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 K143046
Device Name Xario 100, V3.0
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
1385 SHIMOISHIGAMI
OTAWARA-SHI,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Correspondent Contact Orlando Tadeo
Regulation Number892.1550
Classification Product Code
IYN  
Date Received10/22/2014
Decision Date 11/19/2014
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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