gudid Primary ID: Evolution

BI Image-X (UDI Evolution)

Manufactured by Radiotecnologa Industrial, S.A. de C.V.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BI Image-X (Model/Catalog Number: Evolution) is a medical device manufactured by Radiotecnologa Industrial, S.A. de C.V.. This product is indexed under FDA Product Code / Category Classification EHD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Evolution
Product Code / EMDN: EHD
Device Name: The BI IMAGE-X EVOLUTION device is an extraoral x-ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.The BI IMAGE-X EVOLUTION is an extraoral x-ray generator system designed to be used in combination with an intraoral image receptor for radiographic examinations (which assist in diagnosis of diseases of the teeth, jaw, and oral structure) by dental professionals.
Database Sync Date: 2026-08-09 09:03:35

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 BI Image-X?

The registered manufacturer of record for BI Image-X is Radiotecnologa Industrial, S.A. de C.V..

What is the Primary UDI-DI identifier for BI Image-X?

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

What classification code is assigned to this device?

This device is registered under product classification code EHD.

Similar Classification Devices (EHD)

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