AutoContour (RADAC V5)— 510(k) K260509
Substantially EquivalentRadformation, Inc.
FDA 510(k) clearance K260509 for AutoContour (RADAC V5), Substantially Equivalent on 2026-03-19. Applicant: Radformation, Inc.. Device class: 2.
Summary
Radformation's AutoContour (RADAC V5) is filed under QKB, radiological image processing software for radiation therapy. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. It was a Special 510(k), and Radiology is both the classification panel and the review panel.
Radformation filed from New York, New York. The decision came 30 calendar days after FDA received it (February 17 to March 19, 2026).
Clearance details
- Applicant
- Radformation, Inc.
- Product code
- Product code QKB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- New York, NY, US
Recent devices under product code QKB
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