Clearance Summary
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE received FDA 510(k) clearance under submission number K131601, sponsored by Qubyx Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-07-07.
- Submission: K131601
- Applicant / Sponsor: Qubyx Limited
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2014-07-07
Classification & Regulation
This clearance is catalogued under FDA product code PGY and 21 CFR 892.2050, within the Radiology review panel as a Class II device.