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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 software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment.
De Novo Number DEN250028
Device Name DeepView AI® System
Requester
spectralmd, inc.
2515 mckinney ave. suite 1000
dallas,  TX  75201
Contact trudy estridge
Regulation Number878.1840
Classification Product Code
SHY  
Date Received06/27/2025
Decision Date 05/21/2026
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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