# K231001: DeepTek CXR Analyzer v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Deeptek Medical Imaging Pvt, Ltd.
- Decided: Oct 5, 2023 after 181 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P000041 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210666: Chest-CAD, Imagen Technologies, Inc. (2021) Summary page 4.

## Indications for use
DeepTek CXR Analyzer v1.0 is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious ROIs in one of the following categories: Lungs, Pleura, Cardiac, and Hardware. The device is intended for use as a concurrent reading aid for radiologists. DeepTek CXR Analyzer v1.0 is indicated for adults and transitional adolescents (18 to <22 years old but treated like adults) only.

Source page: https://510kreport.com/device/K231001
Methodology: https://510kreport.com/methodology