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 Gastrointesinal Lesion Software Detection System
510(k) Number K230658
Device Name SKOUT® system
Applicant
Iterative Scopes, Inc.
675 Massachusetts Ave.
2nd Floor
Cambridge,  MA  02139
Applicant Contact Dennis Francoeur
Correspondent
Iterative Scopes, Inc.
675 Massachusetts Ave.
2nd Floor
Cambridge,  MA  02139
Correspondent Contact Dennis Francoeur
Regulation Number876.1520
Classification Product Code
QNP  
Date Received03/09/2023
Decision Date 04/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-