Caption Interpretation Automated Ejection Fraction Software

Automated Radiological Image Processing Software

Caption Health

The following data is part of a premarket notification filed by Caption Health with the FDA for Caption Interpretation Automated Ejection Fraction Software.

Pre-market Notification Details

Device IDK200621
510k NumberK200621
Device Name:Caption Interpretation Automated Ejection Fraction Software
ClassificationAutomated Radiological Image Processing Software
Applicant Caption Health 2000 Sierra Point Pkwy Brisbane,  CA  94005
ContactSam Surette
CorrespondentSam Surette
Caption Health 2000 Sierra Point Pkwy Brisbane,  CA  94005
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-07-22

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