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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K260116
Device Name CustoMED Viewer
Applicant
CustoMED , Ltd.
Derech Shiba 64
Ramat Gan,  IL 5266200
Applicant Contact Or Benifla
Correspondent
LDP Consulting
44 Hey Beiyar St.
Tel Aviv,  IL 6215017
Correspondent Contact Esther Kott
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/14/2026
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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