Clearance Summary
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS received FDA 510(k) clearance under submission number K033577, sponsored by Medlink Imaging. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-03-18.
- Submission: K033577
- Applicant / Sponsor: Medlink Imaging
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2005-03-18
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.