MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE

System, Imaging, Pulsed Echo, Ultrasonic

MEDGE PLATFORMS, INC.

The following data is part of a premarket notification filed by Medge Platforms, Inc. with the FDA for Medge Platforms Sonocubic 3d Ultrasound Software.

Pre-market Notification Details

• Device ID: K003672
• 510k Number: K003672
• Device Name: MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: MEDGE PLATFORMS, INC. 90 PARK AVE. 17TH FLOOR New York, NY 10016 -1301
• Contact: Gustavo Eduardo Abella
• Correspondent: Gustavo Eduardo Abella; MEDGE PLATFORMS, INC. 90 PARK AVE. 17TH FLOOR New York, NY 10016 -1301
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-11-28
• Decision Date: 2001-02-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B118314170	K003672	000
B118314160	K003672	000