Clearance Summary
RadiForce MX317W-PA received FDA 510(k) clearance under submission number K242545, sponsored by Eizo Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2025-05-23.
- Submission: K242545
- Applicant / Sponsor: Eizo Corporation
- Clearance pathway: Abbreviated
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2025-05-23
Classification & Regulation
This clearance is catalogued under FDA product code PZZ and 21 CFR 864.3700, within the Pathology review panel as a Class II device.