0.55 Tesla MRI System
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Siemens Shenzhen Magnetic Resonance Ltd.·Registered Feb 28, 2024- Analysis ID
- 240000028/PCBB-BYT
- Submission ID
- 000.00.04.G18-240228-0002
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Siemens Shenzhen Magnetic Resonance Ltd.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Siemens Shenzhen Magnetic Resonance Ltd.
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- Intended Use
- The MAGNETOM Free.Max system is designated as a diagnostic magnetic resonance imaging (MRI) device that produces transverse, sagittal, coronal, and oblique images to display the internal structure and/or function of the head, body, or limbs. Other physical parameters derived from the images may also be obtained. Depending on the area of interest, contrast agents may be used. When the trained physician interprets these images and the physical parameters derived from them, they will obtain information that may support the diagnosis. The MAGNETOM Free.Max system can also be used to create images during interventional procedures when performed with MR-compatible devices such as the MR Safe guidewire (Safe for MR).
- Registration Date
- Feb 28, 2024
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Access comprehensive regulatory information for 0.55 Tesla MRI 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 240000028/PCBB-BYT and manufactured by Siemens Shenzhen Magnetic Resonance Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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