Clearance Summary
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST received FDA 510(k) clearance under submission number K081218, sponsored by It-V Medizintechnik, GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-07-21.
- Submission: K081218
- Applicant / Sponsor: It-V Medizintechnik, GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2008-07-21
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.