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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software Algorithm Device To Assist Users In Digital Pathology
510(k) Number K241232
Device Name Galen™ Second Read™
Applicant
Ibex Medical Analytics , Ltd.
101 Rokach Blvd.
Tel Aviv,  IL 6153101
Applicant Contact Yael Liebes Peer
Correspondent
Ibex Medical Analytics , Ltd.
101 Rokach Blvd.
Tel Aviv,  IL 6153101
Correspondent Contact Yael Liebes Peer
Regulation Number864.3750
Classification Product Code
QPN  
Date Received05/02/2024
Decision Date 01/24/2025
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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