Medical image processing software
- Device class
- Class II
- Model specifications
- See annex见附件
- Approval department
- Tianjin Drug Administration天津市药品监督管理局
- Registration number
- 津械注准20242210121
- Approval date
- November 06, 2024
- Expiry date
- May 05, 2029
- Name
- Tianjin Zhengtian Medical Instrument Co., Ltd.天津正天医疗器械有限公司
- Province/Region
- Tianjin天津
- Address
- No. 318, Jingyi Road, Tianjin Airport Economic Zone天津空港经济区经一路318号
- Production address
- 天津空港经济区经一路 296 号 1 号厂房二层南侧,天津空港经济区经一路318号,天津空港经济区经一路 296 号 1 号厂房二层南侧,天津空港经济区经一路318号
本产品适用于开展CT检查的各级医院影像科等科室,对CT设备生成的符合 DICOM 3.0 标准的骨骼 CT 影像数据进行导入、 三维重建、图像分割及保存导出,不包括自动诊断.
本产品适用于开展CT检查的各级医院影像科等科室，对CT设备生成的符合 DICOM 3.0 标准的骨骼 CT 影像数据进行导入、 三维重建、图像分割及保存导出，不包括自动诊断。
本产品交付内容包括软件安装程序及账号密码,产品功能模块包括:影像数据导入功能、影像数据显示与三维重建、骨骼图像分割功能.
本产品交付内容包括软件安装程序及账号密码，产品功能模块包括：影像数据导入功能、影像数据显示与三维重建、骨骼图像分割功能。
- Changes
- 生产地址变更 20241106
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Medical image processing software in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 津械注准20242210121 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on November 06, 2024.
This page provides complete registration details including registrant information, province location (Tianjin), 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.