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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 K003672
Device Name MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
Applicant
Medge Platforms, Inc.
90 Park Ave.
17th Floor
New York,  NY  10016
Applicant Contact GUSTAVO EDUARDO ABELLA
Correspondent
Medge Platforms, Inc.
90 Park Ave.
17th Floor
New York,  NY  10016
Correspondent Contact GUSTAVO EDUARDO ABELLA
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/28/2000
Decision Date 02/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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