510(k) K242545
K242545 is an FDA 510(k) premarket notification submitted by Eizo Corporation for the device "RadiForce MX317W-PA". The FDA issued a decision of Substantially Equivalent on May 23, 2025. The device falls under product code PZZ (Digital Pathology Display), a Class II device regulated under 21 CFR 864.3700. Eizo Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2025
- Date Received
- August 27, 2024
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Pathology Display
- Device Class
- Class II
- Regulation Number
- 864.3700
- Review Panel
- PA
- Submission Type
The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained pathologists.