Identifiers
- 510(k) Number
- K142718 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 Radlink GPS is a Solid State X-Ray Imager (Flat Panel/Digital Imager), a type of digital radiography detector designed to capture high-resolution radiographic images for diagnostic purposes. It employs a flat-panel detector technology to convert X-ray exposure into digital signals, enabling real-time imaging and improved visualization of anatomical structures. This device is classified under Class II medical devices, indicating moderate regulatory oversight due to its role in critical diagnostic imaging.
The Radlink GPS is intended for use in radiology departments within healthcare settings, where it is integrated into X-ray systems to produce digital radiographic images. Supplied as a reusable device, it requires proper cleaning, disinfection, and maintenance to ensure sterility and functionality. The imager operates within standard MRI-safe environments, adhering to safety guidelines for electromagnetic interference. Authorized under FDA 510K clearance (K142718), it is regulated under the Federal Food, Drug, and Cosmetic Act (21 CFR 892.1680) and falls under the Radiology advisory committee classification.
Frequently asked questions
Is the Radlink GPS designed for single-use or can it be reused in a clinical setting?
The Radlink GPS is a reusable device, as explicitly stated in the description. Since it is intended for integration into X-ray systems within radiology departments, proper cleaning, disinfection, and maintenance are required to ensure its functionality and sterility between uses.
What types of environments is the Radlink GPS compatible with, particularly concerning electromagnetic interference?
The Radlink GPS is designed to operate within standard MRI-safe environments, adhering to safety guidelines for electromagnetic interference. This ensures it can be safely used alongside MRI systems without compromising image quality or patient safety.
How is the regulatory status of the Radlink GPS determined, and what does that mean for its use in healthcare settings?
The Radlink GPS is classified as a Class II medical device under FDA regulations, indicating moderate regulatory oversight. It holds FDA 510K clearance (K142718), meaning it has been deemed substantially equivalent to a legally marketed device and is authorized for use in radiology departments for diagnostic imaging purposes.
Are there specific sizes or models of the Radlink GPS, and how would I determine which one is appropriate for my facility?
The provided data does not specify individual sizes or models of the Radlink GPS, but it lists multiple FEI (Facility Establishment Identifier) numbers, which may correspond to different configurations or installations. For precise sizing or model selection, you would need to consult Radlink, Inc. directly or refer to their technical documentation, as these identifiers relate to facility registrations rather than device specifications.
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 | K142718 | Class II | Active |
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Manufacturer
- Manufacturer
- Radlink, Inc.
Sources (1)
- FDA 510(k) K142718 24 fields · synced Sep 20, 2026