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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 K111098
Device Name INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
Applicant
IMAGING DYNAMICS COMPANY LTD.
8870 ravello ct
naples,  FL  34114
Contact daniel kamm
Regulation Number892.1650
Classification Product Code
MQB  
Date Received04/20/2011
Decision Date 05/27/2011
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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