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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name digital pathology image viewing and management software
510(k) Number K193054
Device Name Sectra Digital Pathology Module
Sectra AB
Teknikringen 20
Linkoping,  SE 58330
Applicant Contact Edoardo Mastrovito
Peter Altman
14 Mercer Road
Savannah,  GA  31411 -1433
Correspondent Contact Peter Altman
Regulation Number864.3700
Classification Product Code
Date Received11/01/2019
Decision Date 03/31/2020
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