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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 K091073
Device Name WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
Applicant
Ultraspect , Ltd.
6 Sireni
Haifa,  IL 32972
Applicant Contact DAN LAOR
Correspondent
Ultraspect , Ltd.
6 Sireni
Haifa,  IL 32972
Correspondent Contact DAN LAOR
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received04/14/2009
Decision Date 05/14/2009
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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