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 K202013
Device Name WRDensity by Whiterabbit.ai
Applicant
Whiterabbit.ai Inc.
3930 Freedom Cir. Ste 101
Santa Clara,  CA  95054
Applicant Contact Jason Su
Correspondent
Whiterabbit.ai Inc.
3930 Freedom Cir. Ste 101
Santa Clara,  CA  95054
Correspondent Contact Jason Su
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/21/2020
Decision Date 10/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-