Clearance Summary
Catalyst+, Catalyst+ HD received FDA 510(k) clearance under submission number K200435, sponsored by C-Rad Positioning AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-05-07.
- Submission: K200435
- Applicant / Sponsor: C-Rad Positioning AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2020-05-07
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.