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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 K243893
Device Name Second Opinion® Pediatric
Applicant
Pearl, Inc.
2515 Benedict Canyon Dr.
Beverly Hills,  CA  90210
Applicant Contact Ashley Brown
Correspondent
Pearl, Inc.
2515 Benedict Canyon Dr.
Beverly Hills,  CA  90210
Correspondent Contact Ashley Brown
Regulation Number892.2070
Classification Product Code
MYN  
Date Received12/18/2024
Decision Date 05/05/2025
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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