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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 K040141
Device Name EMORY CARDIAC TOOLBOX VERSION 2.6
Applicant
Syntermed, Inc.
3340 Peachtree Rd. NE
Suite 1800
Atlanta,  GA  30326
Applicant Contact KENNETH F VAN TRAIN
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact ELIZABETH DREW
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/22/2004
Decision Date 01/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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