Clearance Summary
PIONEER TC8080, COMPANION III received FDA 510(k) clearance under submission number K053648, sponsored by Viasys Neuro Care. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-01-24.
- Submission: K053648
- Applicant / Sponsor: Viasys Neuro Care
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2006-01-24
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.