Pure Global
Singapore HSA registration DE0510110

DeepTek Medical Imaging DeepTek CXR Detect

Singapore flagSingapore·CLASS B·DeepTek Medical Imaging Private Limited·Registered December 05, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0510110
Registration Date
December 05, 2024
Retention Due Date
December 04, 2025
Product description
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.
Product Owner
Name
DeepTek Medical Imaging Private Limited
Short Name
DeepTek Medical Imaging Private Limited
Address
3rd Floor, Ideas to Impact Building, Pallod Farms 3, Behind Vijay Sales, Baner, Pune, Maharashtra 411045, INDIA
Registrant
Name
MEDRA+ PTE. LTD.
Address
6 KITCHENER LINK, CITY SQUARE RESIDENCES, #05-11, SINGAPORE 207227
Model information
Model Name(s)
DeepTek CXR Detect
Model Identifier(s)
DeepTek_003
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B