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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 K160120
Device Name D-SPECT Processing and Reviewing Workstation
Applicant
Spectrum Dynamics , Ltd.
22 Bareket St.
Caesarea,  IL 30889
Applicant Contact YORAM LEVY
Correspondent
Qsite
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received01/19/2016
Decision Date 03/21/2016
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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