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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 K120073
Device Name INFX-8000V WITH
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINES
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINES
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received01/10/2012
Decision Date 01/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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