FDA-cleared K231001
DeepTek CXR Analyzer v1.0
DeepTek Medical Imaging Pvt Ltd
Authorized purpose: Concurrent CADe support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs for radiologist review.
- Modality
- X-ray/Radiography
- Anatomy
- Chest: lungs, pleura, cardiac structures, and hardware
- Decision
- 2023-10-05