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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K162614
Device Name Infinix, INFX-8000V, V6.35
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 JANINE F. REYES
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received09/19/2016
Decision Date 10/17/2016
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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