Vietnam MOH registration 240002094/PCBB-HN

Magnetic Resonance Imaging System

VN: Hệ thống chụp cộng hưởng từ
Vietnam flagVietnam·Risk Class TTBYT Loại B·SIGNA Champion·GE Healthcare (Tianjin) Company Limited·Registered Aug 16, 2024
Registration details
Analysis ID
240002094/PCBB-HN
Submission ID
000.00.19.H26-240711-0005
Product Type
SIGNA Champion
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
GE Healthcare (Tianjin) Company Limited
Technical details
Intended Use
The SIGNA™ Champion system is a whole-body MRI scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is used as a diagnostic imaging device to produce images along the axis, longitudinal, ring, and oblique planes, spectroscopic images, parameter maps and/or functional images of structures and/or functions throughout the body, including but not limited to: head, neck, temporomandibular joint (TMJ), spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and/or the musculoskeletal regions of the body. Contrast agents can be used as required for the region of interest being imaged. The images produced by the SIGNA™ Champion system reflect the spatial distribution or the molecular environment of the nuclei that are undergoing MRI. These images and/or spectra, when interpreted by a trained physician, provide information that can be useful in diagnosis.
Dates and status
Registration Date
Aug 16, 2024
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About this record

Access comprehensive regulatory information for Magnetic Resonance Imaging System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240002094/PCBB-HN and manufactured by GE Healthcare (Tianjin) Company Limited. The authorized representative in Vietnam is CÔNG TY TNHH GE HEALTHCARE VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Siemens Healthcare GmbH, GE Healthcare Manufacturing LLC, 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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