3 Tesla MRI System
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Siemens Healthineers·Registered Oct 23, 2024- Analysis ID
- 240002429/PCBB-HCM
- Submission ID
- 000.00.19.H29-241017-0004
- 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 (MRI) device, producing transverse, sagittal, coronal, and oblique images, as well as MRI spectra and/or spectra, and it displays the internal structure and/or function of the head, body, or limbs. It can also generate 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 physicians, will provide information that may be useful for diagnosis. Your MAGNETOM system can 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 guidewires.
- Registration Date
- Oct 23, 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 240002429/PCBB-HCM and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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