Clearance Summary
UNICORN MODEL SYS0630 received FDA 510(k) clearance under submission number K001888, sponsored by Danish Diagnostic Development A/S. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-06-30.
- Submission: K001888
- Applicant / Sponsor: Danish Diagnostic Development A/S
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2000-06-30
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.