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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(K) Number K122842
Model DRAD-3000E
Device Name RADREX-I, SW V4.00 MODEL DRAD-3000E
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
tustin,  CA  92780
Contact charlemagne chua
Regulation Number892.1650
Classification Product Code
MQB  
Date Received09/17/2012
Decision Date 10/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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