Caption Guidance

Image Acquisition And/or Optimization Guided By Artificial Intelligence

Bay Labs, Inc.

The following data is part of a De Novo classification by Bay Labs, Inc. with the FDA for Caption Guidance.

Pre-market Notification Details

DeNovo IDDEN190040
Device Name:Caption Guidance
ClassificationImage Acquisition And/or Optimization Guided By Artificial Intelligence
Applicant Bay Labs, Inc. 290 King Street San Francisco,  CA  94107
ContactSam Surette
Product CodeQJU  
CFR Regulation Number892.2100 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardRadiology
Classification AdvisoryRadiology
TypeDirect
Date Received2019-08-27
Decision Date2020-02-07
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.