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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 referral of findings related to fibrotic lung disease.
De Novo Number DEN220040
Device Name Fibresolve
Requester
imvaria, inc
1748 shattuck ave. pmb 137
berkley,  CA  94709
Contact joshua reicher
Regulation Number892.2085
Classification Product Code
QWO  
Date Received06/29/2022
Decision Date 01/12/2024
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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