RadiForce MX317W-PA
EIZO CorporationThe RadiForce MX317W-PA is a color LCD monitor designed for displaying digital images of histopathology slides acquired from whole-slide imaging scanners. It aids pathologists in the review and interpretation of these slides for primary diagnosis by providing high-quality image visualization with calibrated display modes and color accuracy.
Intended Use
Intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software validated for this device. Used as an aid to pathologists for review and interpretation for primary diagnosis, excluding certain specimen types.
Technology
The device is a 30.5 inch color LCD monitor employing in-plane switching (IPS) technology with an 8MP resolution (4096 x 2160 pixels) and pixel pitch of 0.1674 mm. It includes factory calibrated display modes stored in internal lookup tables to maintain tone curves, luminance, and color temperature consistency, with integrated optical sensors for calibration and ambient light adjustment.
Performance
Bench tests including spatial resolution, pixel defects, luminance uniformity, grayscale, color scale, and other display quality parameters were performed. Results demonstrated display characteristics equivalent to the predicate device and meeting predefined acceptance criteria, supporting safety and efficacy without animal or clinical testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/27/2024
8 months - 2
FDA Approval
5/23/2025
Other devices from EIZO Corporation
- RadiForce RX570; RadiForce RX570-AR2024 • 510K
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