Agfa Computed Radiography Systems With NX2008 Workstations
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081963 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Agfa Computed Radiography Systems with NX2008 Workstations are solid state X-ray imagers, also known as flat panel or digital imagers. These systems are designed to provide diagnostic quality images to assist physicians in the diagnosis of the skeleton, including the skull, spinal column, and extremities, as well as the chest, abdomen, and other body parts.
The systems utilize Musica, Musica2, or Musica2 Platinum image processing software to create radiographic images. This device is authorized under FDA 510(k) number K081963.
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: Agfa Computed Radiography Systems With Nx2008 Workstations, PDF AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008… - FDA.report, Agfa Computed Radiography Systems With Nx2008 Workstations
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081963 | Class II | Active |
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Manufacturer
- Manufacturer
- Agfa Healthcare Corporation
Sources (1)
- FDA 510(k) K081963 24 fields · synced Sep 26, 2026