Clearance Summary
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES received FDA 510(k) clearance under submission number K141979, sponsored by Philips Medical Systems Netherland BV. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-08-19.
- Submission: K141979
- Applicant / Sponsor: Philips Medical Systems Netherland BV
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2014-08-19
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.