Clearance Summary
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS received FDA 510(k) clearance under submission number K132045, sponsored by Ge Hungary Kft. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-09-04.
- Submission: K132045
- Applicant / Sponsor: Ge Hungary Kft
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5840
- Decision date: 2013-09-04
Classification & Regulation
This clearance is catalogued under FDA product code KPQ and 21 CFR 892.5840, within the Radiology review panel as a Class II device.