Identifiers
- 510(k) Number
- K242545 FDA 510(k)
- FDA Product Code
- PZZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.3700 FDA 510(k)
- Regulation Number
- 864.3700 FDA 510(k)
- Advisory Committee
- Pathology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Digital Pathology Display, a type of medical device used for viewing digital pathology images. It is a 30.5-inch color LCD monitor designed to provide high-detail visualization of microscopic cell and tissue structures.
The RadiForce MX317W-PA is supplied as a reusable monitor with dedicated pathology mode settings for optimized image viewing. It is used in healthcare settings for digital pathology applications and has received FDA 510(k) clearance under k-number K242545, classified as a Class II device with product code PZZ.
Frequently asked questions
What is the RadiForce MX317W-PA used for?
The RadiForce MX317W-PA is a Digital Pathology Display used for viewing digital pathology images, providing high-detail visualization of microscopic cell and tissue structures in healthcare settings.
How is the RadiForce MX317W-PA supplied and is it reusable?
The RadiForce MX317W-PA is supplied as a reusable monitor with dedicated pathology mode settings, designed for repeated use in clinical environments for digital pathology applications.
What are the key specifications of the RadiForce MX317W-PA monitor?
The RadiForce MX317W-PA is a 30.5-inch color LCD monitor with dedicated pathology mode settings, optimized for high-detail visualization of digital pathology images in healthcare settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RadiForce MX317W - 30.5" Color LCD Monitor | EIZO, RadiForce MX317W | EIZO, Product Database MX317W | EIZO CORPORATION, RadiForce MX317W | 8-megapixel monitor with USB-C docking - EIZO
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242545 | Class II | Active |
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Manufacturer
- Manufacturer
- Eizo Corporation
Sources (1)
- FDA 510(k) K242545 24 fields · synced Sep 21, 2026