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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, tomography, computed
510(K) Number K113715
Model CSLV-001A
Device Name LUNG VOLUME ANALYSIS
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin,  CA  92780
Contact paul biggins
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/19/2011
Decision Date 08/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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