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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 K222174
Device Name RadioLens v1.0
Applicant
Synapsica
2591 Dallas Pkwy.
Suite 300
Frisco,  TX  75034
Applicant Contact Meenakshi Singh
Correspondent
Cosm
45 Bartlett St. Unit 706
San Franscisco,  CA  94110
Correspondent Contact Rory A. Carrillo
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/21/2022
Decision Date 03/28/2023
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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