Clearance Summary
8MP COLOR LCD MONITOR, RADIFORCE RX850 received FDA 510(k) clearance under submission number K140702, sponsored by Eizo Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-04-04.
- Submission: K140702
- Applicant / Sponsor: Eizo Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2014-04-04
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.