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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K020561
Device Name SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
Applicant
Tomtec Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE D-85716
Applicant Contact FLORIAN EISENBERGER
Correspondent
Tomtec Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE D-85716
Correspondent Contact FLORIAN EISENBERGER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/20/2002
Decision Date 05/09/2002
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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