AI Contouring (VA10A)
FDA 510(k) K261306 · Varian Medical Systems
510(k) numberK261306
Submission
- Device name
- AI Contouring (VA10A)
- Applicant
- Varian Medical Systems
Palo Alto, CA, US - Received
- April 20, 2026
- Decision date
- July 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKB – Radiological Image Processing Software For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image…
Other 510(k)s with product code QKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262452 | AutoContour (RADAC V6)QKB · Special | Radformation, Inc. | 08/14/2026SE |
| K260528 | OncoStudioQKB · Traditional | Oncosoft. Inc., | 07/02/2026SE |
| K252548 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Healthcare GmbH | 04/10/2026SE |
| K252190 | DeepBT Detector-PlusQKB · Traditional | Aitewan Biomedical Technology, Inc. | 04/10/2026SE |
| K253270 | Contour ProtégéAI+QKB · Traditional | Mim Software, Inc. | 03/27/2026SE |
| K260509 | AutoContour (RADAC V5)QKB · Special | Radformation, Inc. | 03/19/2026SE |
| K251306 | Seg Pro V3 (RT-300)QKB · Traditional | Ever Fortune.Ai, Co., Ltd. | 01/28/2026SE |
| K251351 | AccuContour 4.0QKB · Traditional | Manteia Technologies Co., Ltd. | 01/23/2026SE |
| K250780 | ARTAssistantQKB · Traditional | Manteia Technologies Co., Ltd. | 12/05/2025SE |
| K250427 | TAIMedImg DeepMetsQKB · Traditional | Taiwan Medical Imaging Co., Ltd. | 05/28/2025SE |
More from Taiwan Medical Imaging Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 08/03/2026SE |
| K260750 | Virtual Cone (1.0)MUJ · Traditional | 07/08/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | 06/04/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | 05/20/2026SE |
| K252815 | ProBeam 360 Proton Therapy System v3.0LHN · Traditional | 04/23/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 01/21/2026SE |
| K252919 | Identify (5.0)IYE · Traditional | 12/16/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | 11/19/2025SE |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeamIYE · Traditional | 10/07/2025SE |
Questions and answers
When was AI Contouring (VA10A) cleared by the FDA?
AI Contouring (VA10A) (K261306) received a 510(k) decision of Substantially Equivalent on July 10, 2026, 81 days after the submission was received.
What is the product code of K261306?
The FDA product code is QKB – Radiological Image Processing Software For Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.2050.