Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • 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 Automated Radiological Image Processing Software
510(k) Number K210747
Device Name Caption Interpretation Automated Ejection Fraction Software
Applicant
Caption Health
2000 Sierra Point Pkwy
Brisbane,  CA  94005
Applicant Contact Sam Surette
Correspondent
Manatt, Phelps & Phillips, LLP
1 Embarcadero Center, 30th Floor
San Francisco,  CA  94111
Correspondent Contact Savannah Hari
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/12/2021
Decision Date 01/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-