AI Contouring (VA10A)— 510(k) K261306
Substantially EquivalentVarian Medical Systems
FDA 510(k) clearance K261306 for AI Contouring (VA10A), Substantially Equivalent on 2026-07-10. Applicant: Varian Medical Systems. Device class: 2.
Summary
Varian Medical Systems' AI Contouring (VA10A) is filed under QKB, radiological image processing software for radiation therapy. The record doesn't say which structures the software contours.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Varian filed from Palo Alto, California. Review took 81 calendar days (April 20 to July 10, 2026).
Clearance details
- Applicant
- Varian Medical Systems
- 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
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code QKB
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