Caption Guidance

Image Acquisition And/or Optimization Guided By Artificial Intelligence

Caption Health

The following data is part of a premarket notification filed by Caption Health with the FDA for Caption Guidance.

Pre-market Notification Details

Device IDK201992
510k NumberK201992
Device Name:Caption Guidance
ClassificationImage Acquisition And/or Optimization Guided By Artificial Intelligence
Applicant Caption Health 2000 Sierra Point Pkwy Brisbane,  CA  94005
ContactSam Surette
CorrespondentSam Surette
Caption Health 2000 Sierra Point Pkwy Brisbane,  CA  94005
Product CodeQJU  
CFR Regulation Number892.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-17
Decision Date2020-09-18

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