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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K210365
Device Name Second Opinion
Applicant
Pearl Inc.
2515 Benedict Canyon Drive
Beverly Hills,  CA  90210
Applicant Contact Bill Birdsall
Correspondent
Boston MedTech Advisors
990 Washington Street
Suite 204
Dedham,  MA  02026 -6717
Correspondent Contact Zvi Ladin
Regulation Number892.2070
Classification Product Code
MYN  
Date Received02/08/2021
Decision Date 03/04/2022
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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