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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Linköping,  SE 58330
Applicant Contact Edoardo Mastrovito
Correspondent
Medical Device Regulatory Services
14 Mercer Rd.
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
Predetermined Change
Control Plan Authorized		 No
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