AutoContour (RADAC V6)— 510(k) K262452
Substantially EquivalentRadformation, Inc.
FDA 510(k) clearance K262452 for AutoContour (RADAC V6), Substantially Equivalent on 2026-08-14. Applicant: Radformation, Inc.. Device class: 2.
Summary
Radformation's AutoContour (RADAC V6) is filed under product code QKB, radiological image processing software for radiation therapy. The record doesn't expand RADAC.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. The submission type is Special 510(k).
Radformation filed from New York, New York. FDA found it substantially equivalent 28 calendar days after receipt (July 17 to August 14, 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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