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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 K152697
Device Name INFX-8000C, V6.20
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
1385 SHIMOISHIGAMI
OTAWARA-SHI,  JP 324-8550
Applicant Contact JANINE REYES
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
TUSTIN,  CA  92780
Correspondent Contact JANINE REYES
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received09/21/2015
Decision Date 01/15/2016
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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