Diagnostic X-ray Machine
Vietnam·Risk Class TTBYT Loại C·Optima XR240amx·GE Medical Systems, LLC·Registered Sep 28, 2023- Analysis ID
- 2301020ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220811-0025
- Product Type
- Optima XR240amx
- Manufacturer
- GE Medical Systems, LLC
- Manufacturer Country
- UNITED STATES
- Intended Use
- 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.
- Registration Date
- Sep 28, 2023
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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.
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