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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 diabetic retinopathy detection device
De Novo Number DEN180001
Device Name IDx-DR
458 highway 1 west
iowa city,  IA  52246
Contact michael d. abramoff
Regulation Number886.1100
Classification Product Code
Date Received01/12/2018
Decision Date 04/11/2018
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct