AI Contouring (VA10A)
FDA 510(k) clearance K261306 · decided 2026-07-10
Clearance details
- K-number
- K261306
- Device name
- AI Contouring (VA10A)
- Applicant
- Varian Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2026-04-20
- Decision date
- 2026-07-10
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- QKB
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.