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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 K161740
Device Name D-SPECT Scanner, D-SPECT L Scanner
Applicant
Spectrum Dynamics Medical, Ltd.
22 Bareket St.
North Industrial Park. Caesarea,  IL 3088900
Applicant Contact Igor Naroditsky
Correspondent
Spectrum Dynamics Medical, Ltd.
22 Bareket St.
North Industrial Park. Caesarea,  IL 3088900
Correspondent Contact Igor Naroditsky
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/24/2016
Decision Date 11/04/2016
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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