gudid Primary ID: 5011

EndoSound Vision System (EVS) Software (UDI 5011)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The EndoSound Vision System (EVS) Software (Model/Catalog Number: 5011) is a medical device manufactured by Endosound, Inc.. This product is indexed under FDA Product Code / Category Classification ODG within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 5011
Product Code / EMDN: ODG
Device Name: The EndoSound Vision System (EVS) Software is the Microsoft Windows-based software run on a PC that processes the ultrasound data received from the EVSScanner module and displays the ultrasound image on the PC's monitor.
Database Sync Date: 2026-08-09 09:37:40

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of EndoSound Vision System (EVS) Software?

The registered manufacturer of record for EndoSound Vision System (EVS) Software is Endosound, Inc..

What is the Primary UDI-DI identifier for EndoSound Vision System (EVS) Software?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5011.

What classification code is assigned to this device?

This device is registered under product classification code ODG.

Similar Classification Devices (ODG)

Other Devices by Endosound, Inc.

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