AutoContour (RADAC V6)
FDA 510(k) K262452 · Radformation, Inc.
510(k) numberK262452
Submission
- Device name
- AutoContour (RADAC V6)
- Applicant
- Radformation, Inc.
New York, NY, US - Received
- July 17, 2026
- Decision date
- August 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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…
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| K230685 | AutoContour Model RADAC V3QKB · Special | 04/14/2023SE |
| K220598 | AutoContour Model RADAC V2QKB · Traditional | 08/24/2022SE |
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Questions and answers
When was AutoContour (RADAC V6) cleared by the FDA?
AutoContour (RADAC V6) (K262452) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 28 days after the submission was received.
What is the product code of K262452?
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.