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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name radiological computer assisted detection/diagnosis software for fracture
De Novo Number DEN180005
Device Name OsteoDetect
Requester
imagen technologies, inc.
33 east 33rd street, suite 506
new york,  NY  10016
Contact alex dresner
Regulation Number892.2090
Classification Product Code
QBS  
Date Received02/05/2018
Decision Date 05/24/2018
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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