PET/CT Imaging System
Vietnam·Risk Class TTBYT Loại C·Discovery IQ·GE Medical Systems, LLC·Registered Nov 15, 2022- Analysis ID
- 2200070ĐKLH/BYT-TB-CT
- Submission ID
- 000.00.04.G18-220811-0014
- Product Type
- Discovery IQ
- Manufacturer
- GE Medical Systems, LLC
- Manufacturer Country
- UNITED STATES
- Intended Use
- The PET/CT Discovery IQ system is designed to acquire images of the brain and the whole body, corrected for attenuation and quantifying the radiation activity in the patient's anatomy using integrated PET and CT images. The system is intended for use by trained healthcare specialists to create images of the distribution of radiopharmaceuticals in the body, to assess the metabolic (molecular) and physiological functions of patients of all ages. The device can support the evaluation, diagnosis, staging, restaging, and monitoring of various types of damage, disease, or organ function, including (but not limited to) cancer, cardiovascular disease, and neurological disorders. The device can also support radiation therapy planning. 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 2200070ĐKLH/BYT-TB-CT and manufactured by GE Medical Systems, LLC.
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