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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 K013608
Device Name DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN,  CA  92781 -2068
Applicant Contact DIANA THORSON
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received10/31/2001
Decision Date 11/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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