Singapore HSA registration DE0506606
SenseCare Smart Health Technology SenseCare-Lung Pro Pulmonary CT Diagnostic Software
Singapore·CLASS B·SenseCare Smart Health Technology Co., Ltd.·Registered January 26, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0506606
- Registration Date
- January 26, 2022
- Change Notification Approval Date
- April 25, 2025
- Retention Due Date
- January 25, 2026
Product description
SenseCare-Lung Pro is intended for pulmonary nodules and pneumonia (including COVID-19 pneumonia) detection and analysis of chest CT images which is compliant with DICOM 3.0 standards. SenseCare-Lung Pro use deep learning technology to identify imaging abnormalities. It is only used for auxiliary diagnosis and cannot be used to provide diagnosis results.
Product Owner
- Short Name
- SenseCare Smart Health Technology Co., Ltd.
- Address
- 1900 Hongmei Road, Xuhui District, Shanghai, 200233, CHINA
Registrant
- Name
- ALCOTECH PTE LTD
- Address
- 25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Model information
- Model Name(s)
- SenseCare-Lung Pro Pulmonary CT Diagnostic Software
- Model Identifier(s)
- 6973065280004
About this record
Access comprehensive regulatory information for SenseCare Smart Health Technology SenseCare-Lung Pro Pulmonary CT Diagnostic Software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506606 and owned by SenseCare Smart Health Technology Co., Ltd.. The device was registered on January 26, 2022.
This page provides complete registration details including product owner information, registrant details, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B