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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K223422
Device Name Emory Cardiac Toolbox 4.3
Applicant
Syntermed
245 S. Owens Dr.
Anaheim,  CA  92808
Applicant Contact Kenneth Van Train
Correspondent
Syntermed
245 S. Owens Dr.
Anaheim,  CA  92808
Correspondent Contact Kenneth Van Train
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Codes
JAK   LLZ  
Date Received11/14/2022
Decision Date 03/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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