AutoContour Model RADAC V2
by Radformation, Inc. United States EUDAMED510(k)
510(k) K220598
Product code QKB
Overview
The AutoContour Model RADAC V2 is a radiological image processing software for radiation therapy, classified as a Class II device. It automates the segmentation of anatomical structures and organs at risk (OARs) using deep learning algorithms, generating planning-ready contours from CT, MR, or CBCT imaging data. This software streamlines the contouring process, reducing manual effort and improving consistency in treatment planning workflows.
Supplied as a standalone software solution, the AutoContour Model RADAC V2 is intended for use in radiation oncology departments by trained professionals. It operates on standard clinical imaging systems and does not require additional hardware. The device is cleared under the FDA’s 510(k) pathway as substantially equivalent to predicate devices, with regulatory compliance also meeting EU MDR requirements. No sterility or single-use specifications apply, as it is a reusable digital tool.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK220598 | Date24 Aug 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Radformation, Inc.
Questions
What types of imaging data can the AutoContour Model RADAC V2 process for radiation therapy planning?
The AutoContour Model RADAC V2 is designed to work with CT, MR, and CBCT imaging data. It uses deep learning algorithms to automate the segmentation of anatomical structures and organs at risk, generating planning-ready contours from these modalities to streamline treatment planning workflows.
Is the AutoContour Model RADAC V2 a standalone software solution, or does it require additional hardware?
The AutoContour Model RADAC V2 is supplied as a standalone software solution and does not require any additional hardware. It operates on standard clinical imaging systems already used in radiation oncology departments.
How does the AutoContour Model RADAC V2 improve the workflow for radiation therapy planning?
The AutoContour Model RADAC V2 automates the segmentation of anatomical structures and organs at risk using deep learning, significantly reducing the manual effort required for contouring. This improves consistency in treatment planning workflows and helps trained professionals save time during radiation therapy planning.
What regulatory pathways has the AutoContour Model RADAC V2 followed for clearance?
The AutoContour Model RADAC V2 has been cleared under the FDA’s 510(k) pathway as substantially equivalent to predicate devices. It also meets EU MDR (Medical Device Regulation) compliance requirements, ensuring it adheres to both U.S. and European regulatory standards.
Who is the intended user of the AutoContour Model RADAC V2, and where would it typically be used?
The AutoContour Model RADAC V2 is intended for use in radiation oncology departments by trained professionals, such as radiation oncologists, medical physicists, or radiation therapists. It is specifically designed to assist in the contouring process for radiation therapy planning.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K220598
- EUDAMED