Clearance Summary
IGUIDE SYSTEM received FDA 510(k) clearance under submission number K062611, sponsored by Medical Intelligence Medizintechnik-GmbH-An Elekta. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-09-20.
- Submission: K062611
- Applicant / Sponsor: Medical Intelligence Medizintechnik-GmbH-An Elekta
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2006-09-20
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.