Clearance Summary
CONTOURING DEVICE received FDA 510(k) clearance under submission number K920506, sponsored by X-Icon Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-10-14.
- Submission: K920506
- Applicant / Sponsor: X-Icon Medical Systems
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5840
- Decision date: 1992-10-14
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.