GeneralInterventional (IR)AI / InformaticsDevices & AI clearances
Varian AI Contouring Software Cleared by FDA
U.S. FDA1w ago
The FDA has cleared Varian Medical Systems' AI Contouring (VA10A) software via the 510(k) pathway for automated structure delineation, supporting radiation oncology treatment planning.
- The device is regulated as a radiological computer-assisted contouring system under product code QKB.
- This clearance applies to the U.S. market and follows a radiology-focused committee review.
Automated summary
RadPigeon summaries are original and for information only. They are not clinical advice.