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Diagnostic X-ray Machine - Vietnam Registration 2301020ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Diagnostic X-ray Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2301020ĐKLH/BYT-HTTB and manufactured by GE Medical Systems, LLC.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including OR Technology (Oehm und Rehbein GmbH) , Allengers Medical System Ltd, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2301020ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2301020ĐKLH/BYT-HTTB
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Device Details

Diagnostic X-ray Machine
VN: Máy X-quang chẩn đoán
Risk Class TTBYT Loại C

Registration Details

2301020ĐKLH/BYT-HTTB

000.00.04.G18-220811-0025

Optima XR240amx

Company Information

UNITED STATES

Technical Details

Optima XR240amx is designed to capture images using film, computed radiography (CR), or wireless acquisition, aiming to replace film-based X-ray systems in all multi-purpose diagnostic procedures to enable digital X-ray (DR) imaging. Optima XR240amx is a mobile digital X-ray imaging system powered by batteries, designed to produce diagnostic X-ray images (medical X-rays) that can enhance the ability to detect diseases or injuries early enough to be controlled, treated, or cured. Medical X-rays are used in various types of medical examinations and procedures, some examples include: X-ray imaging (to detect bone fractures, tumors, lung diseases, foreign objects). Optima XR240amx is indicated for use in adults and pediatric patients for various medical examination and general diagnostic X-ray imaging programs. The mobility of the system allows for the performance of general X-ray imaging procedures in all clinical environments, or in emergency, intensive care, neonatal, operating room, and cardiology settings, for patients who are unable to move or in cases where it is unsafe or impractical to move the patient to the conventional RAD room. The system is indicated for skull, spine, chest, abdomen, limbs, and other body parts X-ray imaging when the patient is seated, standing, or lying in an inclined or supine position.

Dates and Status

Sep 28, 2023