DeepTek Medical Imaging DeepTek CXR Detect - HSA Registration DE0510110
Access comprehensive regulatory information for DeepTek Medical Imaging DeepTek CXR Detect in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510110 and owned by DeepTek Medical Imaging Private Limited. The device was registered on December 05, 2024.
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.
DeepTek CXR Detect is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using deep learning algorithms to identify, categorize, and highlight suspicious ROIs in one of the following findings: Opacity, Tuberculosis, Pulmonary Nodules, Fibrosis, Lung Mass, Pneumonia, Atelectasis, Pleural Effusion, Pleural Thickening, Pneumothorax, Foreign bodies, Cardiomegaly, and Rib and clavicular fractures. The device is intended for use as a concurrent reading aid for physicians. DeepTek CXR Detect is indicated for X-rays of patients aged 12 and above.