Identifiers
- 510(k) Number
- K251351 FDA 510(k)
- FDA Product Code
- QKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
AccuContour 4.0 is a radiological image processing software designed for radiation therapy. It specializes in aligning and fusing multiple imaging modalities, including CT, MRI, and PET-CT, to enable precise diagnostic and treatment planning through rigid and deformable registration techniques.
The device is supplied as a digital software solution, intended for use in radiology settings. It has received FDA 510(k) clearance and MDR authorization, with a classification as a Class II medical device. The software supports real-time contour transfer and reflection, facilitating seamless integration of imaging data for enhanced accuracy in clinical workflows.
Frequently asked questions
What types of imaging modalities does the AccuContour 4.0 software support for alignment and fusion in radiation therapy planning?
The AccuContour 4.0 software is designed to align and fuse multiple imaging modalities, specifically CT, MRI, and PET-CT scans. This capability enables precise diagnostic and treatment planning by integrating these different imaging types into a unified dataset for improved accuracy in clinical workflows.
Is the AccuContour 4.0 software intended for single-use or repeated use in a clinical setting?
The AccuContour 4.0 is a digital software solution supplied as a standalone program, meaning it is intended for repeated use within radiology settings. Since it is not a physical consumable or disposable, it can be utilized across multiple patients and procedures as long as it remains properly maintained and updated.
How does the AccuContour 4.0 software enhance the workflow for radiation therapy planning?
The software enhances workflows by providing real-time contour transfer and reflection capabilities, allowing seamless integration of imaging data from different modalities. This feature ensures precise alignment and fusion of CT, MRI, and PET-CT scans, which streamlines diagnostic and treatment planning while reducing manual errors and improving clinical efficiency.
What regulatory pathways has the AccuContour 4.0 software followed, and what does this mean for its use in clinical settings?
The AccuContour 4.0 software has obtained FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, classifying it as a Class II medical device. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in radiation therapy planning, providing confidence in its clinical reliability and compliance with international standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AccuContour | Manteia Official, Manteia Technologies Co., Ltd.: AccuContour 4.0 (FDA ... - usecase.ai, Manteia Technologies Co., Ltd. FDA 510(k) Products - Latest 2026, K251351 FDA 510(k) - AccuContour 4.0
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251351 | Class II | Active |
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Manufacturer
- Manufacturer
- Manteia Technologies Co., Ltd.
Sources (2)
- FDA 510(k) K251351 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026