Vietnam MOH registration 2301200ĐKLH/BYT-HTTB

X-ray Fluorescence Spectrometer

VN: Máy chụp X-quang
Vietnam flagVietnam·Risk Class TTBYT Loại C·XVISION-525·GEMSS HEALTHCARE CO., LTD·Registered Oct 11, 2023
Registration details
Analysis ID
2301200ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230314-0034
Product Type
XVISION-525
Company information
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
XVISION-525 is an X-ray device that produces X-ray images and supports medical diagnosis. It usually takes images of the skull, spine, chest, abdomen, limbs, and other body parts such as the cervix, chest, ribs, forearm, elbow, radius, wrist, hand, pelvis, hip, femur, knee, tibia, fibula, sacrum, coccyx, foot, ankle, and hand. The images obtained through this process help diagnose diseases such as tuberculosis, abdominal and lung diseases, bone fractures, and injuries to the neck, chest, abdomen, lower back, lumbar spine, pelvis, shoulder, elbow, radius, wrist, hand, hip, femur, knee, tibia, fibula, sacrum, coccyx, foot, ankle, and hand. The applications can be performed on patients in various positions, including sitting, standing, or lying prone or supine. The system is designed to be used in all routine X-ray examinations. This device is not intended for pediatric applications, mammography, or dental applications.
Dates and status
Registration Date
Oct 11, 2023
About this record

Access comprehensive regulatory information for X-ray Fluorescence Spectrometer 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 2301200ĐKLH/BYT-HTTB and manufactured by GEMSS HEALTHCARE CO., LTD.

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