RadiForce GX570; RadiForce GX570-AR
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252030 FDA 510(k)
- FDA Product Code
- PGY FDA 510(k)
- Models / Variants
- RadiForce GX570 FDA 510(k)RadiForce GX570-AR 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 GX570 and RadiForce GX570-AR are diagnostic radiology displays designed for medical imaging applications. These devices function as high-resolution monitors intended to provide clear and accurate visualization of diagnostic images.
These displays are regulated as Class 2 medical devices under FDA 510(k) clearance, identified by k-number K252030. The product line includes anti-glare and anti-reflection screen variations to accommodate different ambient lighting environments.
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: PDF RadiForce GX570 - eizo.webcdn-ec.global.stream.ne.jp, Product Database GX570 | EIZO CORPORATION, RadiForce GX570; RadiForce GX570-AR (K252030) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252030 | Class II | Active |
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Manufacturer
- Manufacturer
- Eizo Corporation
Sources (1)
- FDA 510(k) K252030 24 fields · synced Oct 6, 2026