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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 K240724
Device Name SynthVISION 1.0.0
Applicant
Synthesis Health Intelligence, Inc.
22420 Dewdney Trunk Rd., Suite 300
Maple Ridge,  CA V2X 3J5
Applicant Contact Amy Gilchrist
Correspondent
Synthesis Health Intelligence, Inc.
22420 Dewdney Trunk Rd., Suite 300
Maple Ridge,  CA V2X 3J5
Correspondent Contact Amy Gilchrist
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/18/2024
Decision Date 08/08/2024
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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