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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 K152696
Device Name INFX-8000V, V6.20
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 Received09/21/2015
Decision Date 01/12/2016
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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