AutoContour (Model RADAC V4)
by Radformation, Inc. United States EUDAMED510(k)
510(k) K242729 Product code QKB
Overview
AutoContour (Model RADAC V4) 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) from CT and MR images, generating precise contours to support radiation treatment planning.
This software is designed for use in radiation oncology settings and is supplied as a digital tool requiring integration with compatible imaging systems. It is intended for single-use per session, with no sterility requirements. The device holds FDA 510(k) clearance under submission K242729 and is compliant with the Medical Device Regulation (MDR). No MRI safety classification is specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK242729 | Date9 Dec 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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 clinical setting is the AutoContour (Model RADAC V4) designed for, and how does it integrate with existing workflows?
The AutoContour (Model RADAC V4) is specifically designed for radiation oncology settings, where it automates the segmentation of anatomical structures and organs at risk (OARs) from CT and MR images. It serves as a digital tool that must be integrated with compatible imaging systems to generate precise contours for radiation treatment planning. This integration streamlines workflows by reducing manual contouring time, though it requires compatibility with existing imaging infrastructure.
Is the AutoContour (Model RADAC V4) reusable or intended for single-use, and are there any sterility requirements?
The AutoContour (Model RADAC V4) is intended for single-use per session, meaning it is designed to be used once for a specific radiation treatment planning session. Since it is a software-based tool and not a physical medical device requiring direct patient contact, there are no sterility requirements. It operates digitally and does not need sterilization.
What regulatory pathways has the AutoContour (Model RADAC V4) followed, and how does this affect its use in clinical practice?
The AutoContour (Model RADAC V4) has obtained FDA 510(k) clearance under submission K242729, demonstrating it is classified as substantially equivalent to a predicate device. It is also compliant with the Medical Device Regulation (MDR). These clearances indicate that the device has undergone regulatory review to ensure safety and effectiveness, allowing clinicians to use it with confidence in radiation therapy planning while adhering to established standards.
How does the AutoContour (Model RADAC V4) differ from manual contouring methods, and what are its primary benefits?
The AutoContour (Model RADAC V4) automates the segmentation process, reducing the time and effort required for manual contouring of anatomical structures and organs at risk from CT or MR images. By generating precise contours, it helps improve accuracy and consistency in radiation treatment planning, which can lead to more efficient workflows and potentially better patient outcomes. This digital tool is particularly useful in radiation oncology to minimize human error and variability.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K242729
- EUDAMED