Digital Diagnostic X-ray System (GC80)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K143029 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 Digital Diagnostic X-ray System (GC80) is a stationary radiology device that captures digital X-ray images for diagnostic purposes. It includes components such as a ceiling mounted tube head unit, x-ray tube assembly, high voltage generator, wall mounted and portable digital detectors, automatic collimator, scatter radiation grid, patient table, wall stand, and automatic exposure control.
The system is supplied with various detector sizes and is designed for use in radiology settings. It is a Class II medical device with FDA 510(k) clearance (K143029) and is manufactured by Samsung Electronics Co., Ltd. The device includes dose area product monitoring capabilities and is intended for stationary use in diagnostic imaging applications.
Frequently asked questions
What components are included with the Digital Diagnostic X-ray System GC80?
The system includes a ceiling mounted tube head unit, x-ray tube assembly, high voltage generator, wall mounted and portable digital detectors, automatic collimator, scatter radiation grid, patient table, wall stand, and automatic exposure control.
What is the intended use of the GC80 Digital Diagnostic X-ray System?
The GC80 is a stationary radiology device designed to capture digital X-ray images for diagnostic purposes in radiology settings. It is intended for stationary use in diagnostic imaging applications.
What detector sizes are available with the GC80 system?
The system is supplied with various detector sizes to accommodate different imaging needs. The specific sizes available would need to be confirmed with the manufacturer or supplier as they are not detailed in the provided information.
What is the regulatory status of the Digital Diagnostic X-ray System GC80?
The GC80 is a Class II medical device with FDA 510(k) clearance (K143029) and is manufactured by Samsung Electronics Co., Ltd. It has been determined to be substantially equivalent to predicate devices.
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: Technical Data: An Innovative & Cutting-Edge Digital Radiography System, GC80 | Samsung Support UK, Samsung XGEO GC80 Digital Radiography | PDF | X Ray | Radiography - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143029 | Class II | Active |
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Manufacturer
- Manufacturer
- Samsung Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K143029 24 fields · synced Sep 25, 2026