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 Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K212616
Device Name Koios DS
Applicant
Koios Medical, Inc.
242 West 38th Street, 14th Floor
New York,  NY  10018
Applicant Contact Patricia Setti-Laperch
Correspondent
Koios Medical, Inc.
242 West 38th Street, 14th Floor
New York,  NY  10018
Correspondent Contact Patricia Setti-Laperch
Regulation Number892.2060
Classification Product Code
POK  
Subsequent Product Code
QIH  
Date Received08/18/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-