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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K243230
Device Name Second Opinion® BLE
Applicant
Pearl, Inc.
2515 Benedict Canyon Dr.
Beverly Hills,  CA  90210
Applicant Contact William Birdsall
Correspondent
Pearl, Inc.
2515 Benedict Canyon Dr.
Beverly Hills,  CA  90210
Correspondent Contact Ashley Brown
Regulation Number892.2050
Classification Product Code
QIH  
Date Received10/08/2024
Decision Date 05/09/2025
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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