MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE by MEDGE PLATFORMS, INC. | FDA 510(k) Summary

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K Number

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Device Name

MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE

Manufacturer

MEDGE PLATFORMS, INC.

Date Cleared

2001-02-22

(86 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

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Regulation Number and Section

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