Automatic Anatomy Recognition (AAR)
by Quantitative Radiology Solutions, LLC
510(k) K203610
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203610 | Date20 Apr 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
Automatic Anatomy Recognition (AAR) is a radiological image processing software designed for radiation therapy. It functions as a computer-assisted tool to automatically identify and contour anatomical structures from computed tomography (CT) scans, aiding in precise treatment planning for radiotherapy.
The device is supplied as a software-only solution and is intended for use by trained professionals, including technicians and physicians. It operates within a Picture Archiving and Communication System (PACS) environment, adhering to regulatory standards under 21 CFR 892.2050. The device received FDA 510(k) clearance (K203610) as substantially equivalent to a predicate device, with no third-party involvement in its submission.
Questions
AI-generated answers, 1 Oct 2026
What is the Automatic Anatomy Recognition (AAR) software used for?
The Automatic Anatomy Recognition (AAR) software is designed as a computer-assisted tool for radiation therapy. It automatically identifies and contours anatomical structures from CT scans, streamlining the treatment planning process for clinicians. This reduces manual effort and enhances the accuracy of radiotherapy by ensuring precise delineation of critical areas.
How is the AAR software supplied and where does it operate?
The AAR software is supplied exclusively as a software-only solution. It is intended to integrate seamlessly within a Picture Archiving and Communication System (PACS) environment, where trained professionals—such as technicians and physicians—can utilize it for radiotherapy planning. This integration ensures compatibility with existing clinical workflows.
Is the AAR software single-use or reusable?
The AAR software is not a physical device with a single-use or reusable classification in the traditional sense. As a software solution, it is installed and used repeatedly within a PACS environment, provided the system remains compliant with regulatory standards. The software itself does not degrade or become unusable after a single application, but its performance depends on the underlying hardware and system maintenance.
Does the AAR software require any special storage or handling?
Since the AAR software is a digital solution, it does not require physical storage like traditional medical devices. However, it must be installed on compliant, secure, and properly maintained hardware within a PACS environment. Regular software updates and system backups are recommended to ensure optimal performance and compliance with regulatory requirements, such as those outlined under 21 CFR 892.2050.
What regulatory pathway was followed for the AAR software’s clearance?
The AAR software received FDA 510(k) clearance (K203610) through a traditional review pathway, demonstrating substantial equivalence to a predicate device. The submission was filed under the Radiology advisory committee (RA) and did not involve third-party participation. This clearance confirms the software meets regulatory standards for use in automating anatomical contouring for radiation therapy planning.