DeepTek CXR Analyzer v1.0
by Deeptek Medical Imaging Pvt, Ltd. 510(k)
Active
510(k) K231001
Overview
The DeepTek CXR Analyzer v1.0 is a computer-assisted detection (CADe) software device designed for analyzing chest radiograph (CXR) studies. It employs machine learning algorithms to identify, categorize, and highlight regions of interest (ROIs) within images, specifically in the lungs, pleura, cardiac, and hardware categories. This device falls under the classification of a medical image analyzer, aiding radiologists in detecting potential abnormalities during diagnostic evaluations.
The DeepTek CXR Analyzer v1.0 is supplied as a software solution for use in radiology settings, where it integrates with existing imaging systems to process and analyze digital chest X-ray images. It is not described as single-use or reusable but operates as a standalone software application requiring compatible hardware for execution. The device has received FDA clearance under the 510(k) pathway, specifically classified as a Class II medical device (K231001). No information regarding sterility, MRI safety, or physical size is provided, as it is a software-based solution.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231001 | Date5 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2070
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What specific types of abnormalities does the DeepTek CXR Analyzer v1.0 help radiologists identify in chest X-rays?
The DeepTek CXR Analyzer v1.0 uses machine learning to identify and highlight regions of interest (ROIs) in chest radiographs, focusing on the lungs, pleura, and cardiac areas. It categorizes findings to assist radiologists in detecting potential abnormalities during diagnostic evaluations, though it does not provide a definitive diagnosis on its own.
How is the DeepTek CXR Analyzer v1.0 supplied and what hardware compatibility does it require?
The DeepTek CXR Analyzer v1.0 is supplied as a standalone software solution designed for integration with existing radiology imaging systems. It requires compatible hardware to execute, but no specific hardware details (e.g., operating system, server specs) are provided in the data. It is not a physical device and does not involve sterility or reuse considerations.
What regulatory pathway was followed for FDA clearance of the DeepTek CXR Analyzer v1.0, and what classification does it hold?
The DeepTek CXR Analyzer v1.0 received FDA clearance through the 510(k) pathway, specifically under the traditional review process. It is classified as a Class II medical device (K231001) and is intended for use as a computer-assisted detection (CADe) tool in radiology settings, aiding in the analysis of chest X-rays.
Does the DeepTek CXR Analyzer v1.0 support multiple digital X-ray formats, or is it limited to specific imaging systems?
The data does not specify which digital X-ray formats or imaging systems are compatible with the DeepTek CXR Analyzer v1.0, but it is designed to integrate with existing radiology imaging systems. The focus is on its software functionality rather than hardware limitations, so compatibility would depend on the manufacturer’s integration guidelines for supported platforms.
How does the DeepTek CXR Analyzer v1.0 differ from traditional radiology tools in terms of its role in diagnostic workflows?
Unlike traditional radiology tools, the DeepTek CXR Analyzer v1.0 is a computer-assisted detection (CADe) software that employs machine learning to automatically identify and categorize regions of interest in chest X-rays. It serves as an auxiliary tool to assist radiologists by highlighting potential abnormalities in the lungs, pleura, and cardiac areas, thereby streamlining the diagnostic process rather than replacing manual interpretation.