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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K133553
Device Name KALARE
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
TUSTIN,  CA  92780 -2068
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
TUSTIN,  CA  92780 -2068
Correspondent Contact PAUL BIGGINS
Regulation Number892.1650
Classification Product Code
JAA  
Date Received11/19/2013
Decision Date 06/13/2014
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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