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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K140651
Device Name CELESTEION, PCA-9000A/2
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/13/2014
Decision Date 06/11/2014
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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