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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 K072468
Device Name MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
Applicant
Spectrum Dynamics , Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Spectrum Dynamics , Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/04/2007
Decision Date 10/01/2007
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
Recalls CDRH Recalls
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