Identifiers
- 510(k) Number
- K181609 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)
This device is a diagnostic radiology display used for medical imaging interpretation. It is a high-resolution monitor designed to support accurate visualization of radiological images such as X-rays, CT scans, and MRIs.
The RadiForce GX560 and GX560-AR models are supplied as reusable, non-sterile devices intended for use in clinical radiology settings. They are authorized under FDA 510(k) clearance (K181609) as Class II medical devices with product code PGY and are indicated for use in diagnostic radiology applications.
Frequently asked questions
What is the RadiForce GX560 GX560-AR used for?
The RadiForce GX560 and GX560-AR are diagnostic radiology displays designed to support accurate visualization of medical images such as X-rays, CT scans, and MRIs. They are intended for use in clinical radiology settings where precise image interpretation is required for diagnosis.
Is the RadiForce GX560 GX560-AR sterile or non-sterile, and is it single-use or reusable?
The RadiForce GX560 and GX560-AR are supplied as non-sterile, reusable devices. They are not intended for single-use and can be used repeatedly in clinical environments after appropriate cleaning, as they are designed for ongoing use in diagnostic radiology workflows.
What regulatory authorization does the RadiForce GX560 GX560-AR have?
The RadiForce GX560 and GX560-AR are authorized under FDA 510(k) clearance (K181609) as Class II medical devices with product code PGY. This clearance indicates they are substantially equivalent to legally marketed predicate devices for diagnostic radiology applications.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181609 | Class II | Active |
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Manufacturer
- Manufacturer
- Eizo Corporation
Sources (1)
- FDA 510(k) K181609 24 fields · synced Sep 21, 2026