Identifiers
- 510(k) Number
- K170949 FDA 510(k)
- FDA Product Code
- PGY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RadiForce MX315W is a diagnostic radiology display device designed for medical imaging review. As a high-resolution monitor, it supports DICOM Part 14 calibration and is classified under the FDA’s diagnostic radiology display category (PGY). With an 8-megapixel resolution and 31.1-inch screen, it is optimized for simultaneous display of multiple imaging modalities, including CT, MRI, and ultrasound, enabling comprehensive clinical assessment.
This device is intended for use in radiology settings, where it is supplied as a reusable, non-sterile medical display. It requires proper calibration and maintenance, supported by bundled software for quality control and asset management. The RadiForce MX315W holds an FDA 510(k) clearance (K170949) under the Traditional pathway, with a decision date of April 27, 2017, and is regulated under FDA regulation number 892.2050. Storage and handling follow standard medical imaging equipment protocols.
Frequently asked questions
What is the RadiForce MX315W used for in a clinical setting?
The RadiForce MX315W is a diagnostic radiology display device designed specifically for reviewing medical images in radiology departments. Its 8-megapixel resolution and 31.1-inch screen enable clear visualization of multiple imaging modalities—such as CT scans, MRI, and ultrasound—simultaneously. This allows clinicians to perform comprehensive assessments and diagnostic evaluations with high precision.
Is the RadiForce MX315W a single-use or reusable device?
The RadiForce MX315W is supplied as a reusable medical display device. It is not intended for sterile procedures, so it is not sterilized for single-use applications. Proper cleaning and maintenance protocols must be followed to ensure optimal performance and hygiene in clinical environments.
What software is included with the RadiForce MX315W for calibration and quality control?
The RadiForce MX315W comes bundled with software designed for calibration and quality control, including DICOM Part 14 compliance tools. This software supports routine maintenance tasks such as monitor calibration, ensuring accurate image display for diagnostic purposes. It also includes asset management features to track usage and performance over time.
How should the RadiForce MX315W be stored and handled?
The RadiForce MX315W should be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Since it is a reusable diagnostic display, it should be kept in a designated area within radiology departments to prevent contamination or misuse. Follow manufacturer guidelines for proper handling to maintain calibration and longevity.
What regulatory pathway does the RadiForce MX315W follow in the U.S.?
The RadiForce MX315W holds FDA 510(k) clearance (K170949) under the Traditional pathway, classified under the diagnostic radiology display category (PGY). This clearance confirms that the device meets FDA standards for safety and effectiveness as a substantially equivalent diagnostic imaging display. It is regulated under FDA regulation number 892.2050.
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: MX315W 8MP 31.1" Precision Monitor - RadiForce | EIZO, Manuals MX315W | EIZO CORPORATION, PDF RadiForce MX315W Instructions for Use - eizoglobal.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170949 | Class II | Active |
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Manufacturer
- Manufacturer
- Eizo Corporation
Sources (1)
- FDA 510(k) K170949 24 fields · synced Oct 1, 2026