PET/CT Imaging System
Vietnam·Risk Class TTBYT Loại C·Discovery MI Digital Ready·GE Medical Systems, LLC·Registered Nov 15, 2022- Analysis ID
- 2200069ĐKLH/BYT-TB-CT
- Submission ID
- 000.00.04.G18-220811-0022
- Product Type
- Discovery MI Digital Ready
- Manufacturer
- GE Medical Systems, LLC
- Manufacturer Country
- UNITED STATES
- Intended Use
- The PET/CT Discovery MI Digital Ready system is designed to produce images of positron emission (PET) of the head and the whole body, corrected for attenuation and determined the radioactivity activity in the patient's region of interest by the combined PET and CT images. The system is intended for use by trained healthcare specialists to produce images of the distribution of radiopharmaceuticals in the body, to serve the evaluation of the metabolic (molecular) and physiological functions in patients of all ages. The device can support the evaluation, diagnosis, staging, restaging, and monitoring of various types of tumors, diseases, or organ functions, such as (but not limited to) cancer, cardiovascular diseases, and brain dysfunction. The device can also support the planning of radiation therapy. The system can be used as a diagnostic computed tomography (CT) imaging device for the whole body and head.
- Registration Date
- Nov 15, 2022
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Access comprehensive regulatory information for PET/CT Imaging System 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 2200069ĐKLH/BYT-TB-CT and manufactured by GE Medical Systems, LLC.
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