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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 K254001
Device Name VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
Applicant
Spectrum Dynamics Medical, Ltd.
22 Bareket St.
Caesarea,  IL 3079837
Applicant Contact Igor Naroditsky
Correspondent
Spectrum Dynamics Medical, Ltd.
22 Bareket St.
Caesarea,  IL 3079837
Correspondent Contact Igor Naroditsky
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Codes
JAK   LLZ   QIH  
Date Received12/15/2025
Decision Date 01/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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