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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 K221065
Device Name MediLab
Applicant
Sigma Scientific Services, LLC
7737 N University Dr., Suite 101
Tamarac,  FL  33321
Applicant Contact Jorge Millan
Correspondent
Sigma Scientific Services, LLC
7737 N University Dr., Suite 101
Tamarac,  FL  33321
Correspondent Contact Jorge Millan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/12/2022
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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