3 Tesla MRI System
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Siemens Healthineers·Registered Aug 29, 2024- Analysis ID
- 240000071/PCBB-BYT
- Submission ID
- 000.00.04.G18-240829-0001
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Siemens Healthineers
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Siemens Healthineers
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- Intended Use
- Your MAGNETOM system is designated for use as a diagnostic magnetic resonance imaging (MRDD) device, producing transverse, sagittal, coronal and oblique images, MR spectra and/or spectra, and it displays the internal structure and/or function of the head, body or limbs. It may also produce physical parameters derived from the images and/or spectra. Depending on the area of interest, it may use a contrast agent. The images and/or spectra, and the physical parameters derived from the images and/or spectra, when interpreted by the specialist physician, will provide information that may support the diagnosis. Your MAGNETOM system may also be used to process images in interventional procedures when performed with MR-compatible devices such as the monitors in the MRI room and the MR-Safe needles.
- Registration Date
- Aug 29, 2024
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Access comprehensive regulatory information for 3 Tesla MRI System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240000071/PCBB-BYT and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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