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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 radiological machine learning based quantitative imaging software with change control plan
De Novo Number DEN220063
Device Name Caption Interpretation Automated Ejection Fraction Software
Requester
caption health, inc
2000 sierra point parkway, 8th floor
brisbane,  CA  94005
Contact tahir rizvi
Regulation Number892.2055
Classification Product Code
QVD  
Date Received09/28/2022
Decision Date 02/24/2023
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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