Vietnam MOH registration 2402887ĐKLH/BYT-HTTB

SPECT/CT System

VN: Hệ thống SPECT/CT

Vietnam·Risk Class TTBYT Loại C·Symbia Pro.specta X7·Siemens Medical Solutions USA, Inc.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402887ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220425-0020
Product Type: Symbia Pro.specta X7
Product Code: 11364753

Company information

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Siemens Medical Solutions USA, Inc.
Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: The Symbia Pro.specta X7 is a combined X-ray fluoroscopy system that integrates a single-photon computed tomography (SPECT) camera system, used for medical nuclear imaging, and a CT camera system, used for X-ray fluoroscopy. The SPECT system is designed to locate and map the position and distribution of gamma-emitting radionuclides in the body, creating cross-sectional images through the process of computerized data reconstruction, while the CT system is designed to create cross-sectional images of the body through the process of computerized reconstruction of X-ray transmission data at different angles in the same axial slice. The nuclear medicine images and X-ray fluoroscopy images can be registered and displayed in a unified format (superimposed on the same orientation) for the region of interest of the nuclear medicine data (i.e., the distribution of the radiopharmaceutical). The SPECT and CT functions of the system can be used independently or combined and can include display and signal analysis equipment, patient support and positioning components, radiopharmaceuticals, and accessories. The SPECT and CT images can be transferred to other systems for radiation therapy planning or further use.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for SPECT/CT 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 2402887ĐKLH/BYT-HTTB and manufactured by Siemens Medical Solutions USA, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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