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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 K241546
Device Name aiCockpit AI Viewer
Applicant
Fovia, Inc.
P.O. Box 1858
Ross,  CA  94957
Applicant Contact Paula Brown
Correspondent
Fovia, Inc.
P.O. Box 1858
Ross,  CA  94957
Correspondent Contact Paula Brown
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/31/2024
Decision Date 02/26/2025
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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