Clearance Summary
VERADIUS UNITY received FDA 510(k) clearance under submission number K142708, sponsored by Philips Medical Systems Nethrlands BV. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-10-22.
- Submission: K142708
- Applicant / Sponsor: Philips Medical Systems Nethrlands BV
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2014-10-22
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.