Revolution XR/D Digital Radiographic Imaging System With Tomosynthesis
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051967 FDA 510(k)
- FDA Product Code
- KPR 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 Revolution XR/D Digital Radiographic Imaging System With Tomosynthesis is a stationary X-ray system used for digital radiographic imaging. It is designed to produce detailed images for diagnostic purposes in radiology.
The system is manufactured by GE Healthcare and is authorized under FDA 510K clearance with device class 2. It is supplied with various registration numbers and is regulated under number 892.1680. The system is intended for stationary use in radiology settings.
Frequently asked questions
What is the Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis used for?
The Revolution XR/D is a stationary X-ray system designed for digital radiographic imaging with tomosynthesis capabilities. It produces detailed images for diagnostic purposes specifically in radiology settings.
How is the Revolution XR/D system supplied and what are its regulatory specifications?
The system is supplied with various registration numbers and is regulated under number 892.1680. It has received FDA 510K clearance with device class 2, indicating it is substantially equivalent to other legally marketed devices.
What are the key features of the Revolution XR/D system?
The Revolution XR/D is a stationary X-ray system that combines digital radiographic imaging with tomosynthesis technology. It is manufactured by GE Healthcare and is designed for use in radiology departments to produce detailed diagnostic images.
Is the Revolution XR/D system reusable or single-use?
The device data does not specify whether the Revolution XR/D system is designed for single-use or multiple reuse. As a stationary X-ray system, it appears to be intended for repeated clinical use in radiology settings rather than disposable single-use 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. Sources consulted: Revolution - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051967 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K051967 24 fields · synced Sep 23, 2026