Clearance Summary
CIRRUS OPEN received FDA 510(k) clearance under submission number K090080, sponsored by Mri-Tech Sp. Zo.O.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-03-23.
- Submission: K090080
- Applicant / Sponsor: Mri-Tech Sp. Zo.O.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2009-03-23
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.