• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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
Caption Health, Inc
2000 sierra point parkway, 8th floor
brisbane,  CA  94005
Contact tahir rizvi
Regulation Number892.2055
Classification Product Code
Date Received09/28/2022
Decision Date 02/24/2023
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Reclassification Order Reclassification Order
Type Direct