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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 gastrointestinal capsule endoscopy analysis software device
De Novo Number DEN230027
Device Name NaviCam ProScan
Requester
ankon technologies co., ltd
b3-2, b3-3, d3-4 biolake, no.666, hi-tech road,
east lake new, technology development zone
wuhan,  CN 430075
Contact feng wang
Regulation Number876.1540
Classification Product Code
QZF  
Date Received04/14/2023
Decision Date 12/12/2023
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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