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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 radiology software for opportunistic evaluation of low bone mineral density
De Novo Number DEN230023
Device Name Rho
Requester
16 bit inc
76 parker ave
ancaster,  CA l9g1a7
Contact dr. catriona syme
Regulation Number892.1171
Classification Product Code
SAO  
Date Received04/03/2023
Decision Date 04/09/2024
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
Type Direct
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