FDA-cleared K231001

DeepTek CXR Analyzer v1.0

DeepTek Medical Imaging Pvt Ltd

Concurrent CADe support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs...

Modality
X-ray/Radiography
Anatomy
Chest: lungs, pleura, cardiac structures, and hardware
Decision
2023-10-05