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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 K110785
Device Name KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
Applicant
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/21/2011
Decision Date 05/27/2011
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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