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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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De Novo Number DEN250007
Device Name Delivery Date AI
Requester
ultrasound ai
8400 e crescent pkwy.
suite 640
greenwood village,  CO  80111
Contact robert bunn
Classification Product Code
SHE
Date Received03/17/2025
Decision Date 02/11/2026
Decision granted (DENG)
Review Advisory Committee Radiology
Type Direct
Predetermined Change
Control Plan Authorized		 No
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