Singapore HSA registration DE0508036
SenseCare Smart Health Technology SenseCare-Chest DR Pro Chest X-Ray Diagnostic Software
Singapore·CLASS B·SenseCare Smart Health Technology Co., Ltd.·Registered April 25, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508036
- Registration Date
- April 25, 2023
- Change Notification Approval Date
- April 25, 2025
- Retention Due Date
- April 24, 2026
Product description
SenseCare-Chest DR Pro is compliant with DICOM 3.0 standards, using deep learning technology to identify imaging abnormalities of pneumonia, tuberculosis, pneumothorax, pleural effusion, cardiomegaly, and rib fracture and provides quantification analysis results for adults only. This product is only used for assisted diagnosis, cannot be used alone for diagnosis. The final diagnosis result should be given by a qualified professional.
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-Chest DR Pro Chest X-Ray Diagnostic Software
- Model Identifier(s)
- 6973065280035
About this record
Access comprehensive regulatory information for SenseCare Smart Health Technology SenseCare-Chest DR Pro Chest X-Ray 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 DE0508036 and owned by SenseCare Smart Health Technology Co., Ltd.. The device was registered on April 25, 2023.
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