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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