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 whole slide imaging system
510(k) Number K232208
Device Name Sectra Digital Pathology Module (Version 3.3)
Applicant
Sectra AB
Teknikringen 20
Linkoping,  SE 58330
Applicant Contact Edoardo Mastrovito
Correspondent
Medical Device Regulatory Services
14 Mercer Road
Savannah,  GA  31411
Correspondent Contact Peter Altman
Regulation Number864.3700
Classification Product Code
PSY  
Subsequent Product Code
QKQ  
Date Received07/26/2023
Decision Date 04/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-