X-ray computed tomography equipment
- Device class
- Class III
- Model specifications
- ZS-CT51-A
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243061741
- Approval date
- September 12, 2024
- Expiry date
- September 11, 2029
- Name
- Shandong Zhushi Pharmaceutical Group Co., Ltd.山东朱氏药业集团有限公司
- Province/Region
- Shandong山东
- Address
- South of Fanlou Road, Shanxian Development Zone单县开发区樊楼路南
- Production address
- 山东单县经济技术开发区食品药品产业园单德路6号
This product is used for routine clinical CT examination.
本产品用于常规临床CT检查。
X-ray computed tomography equipment consists of a scanner (containing X-ray tube assembly, high-voltage generator, detector), patient stand, console assembly (workstation, monitor, scan control box, patient intercom system), power adapter, accessories, and foot switch (optional).
X射线计算机体层摄影设备由扫描架(包含X射线管组件、高压发生器、探测器)、患者支架、控制台组件(工作站、显示器、扫描控制盒、患者对讲系统)、电源适配器、附件和脚踏开关(选配)组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for X-ray computed tomography equipment in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243061741 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on September 12, 2024.
This page provides complete registration details including registrant information, province location (Shandong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.