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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K243144
Device Name X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Applicant
Scopio Labs , Ltd.
10 Hasharon St.
Tel Aviv,  IL 6618502
Applicant Contact Ifat Raved
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number864.5260
Classification Product Code
JOY  
Date Received09/30/2024
Decision Date 06/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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