CareView 1800 RF X-ray Flat Panel Detectors
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221549 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 CareView 1800 RF X-ray Flat Panel Detectors are Solid State X-Ray Imagers (Flat Panel/Digital Imager) per FDA classification. These devices convert X-ray energy into digital signals for real-time radiographic imaging, enabling high-resolution diagnostic views in radiology applications. Their flat-panel design allows for versatile positioning and integration with various X-ray systems, supporting both stationary and mobile imaging setups. The detectors feature radiofrequency (RF) connectivity for seamless data transmission to imaging workstations.
These detectors are supplied as reusable medical devices, intended for use in radiology departments and imaging centers. They are not sterile and require cleaning and maintenance per manufacturer guidelines. The devices are classified as Class II under FDA regulations (892.1680) and have received FDA 510(k) clearance and MDR authorization. Multiple model variants are listed under registration numbers such as 3009717300, 3015223550, and others, each corresponding to specific detector sizes or configurations. Storage and handling must comply with manufacturer instructions to ensure optimal performance and longevity.
Frequently asked questions
Are these X-ray Flat Panel Detectors (CareView 1800 RF) designed for single-use or reusable applications in radiology settings?
The CareView 1800 RF X-ray Flat Panel Detectors are explicitly listed as reusable medical devices for use in radiology departments and imaging centers. Since they are not sterile and require cleaning and maintenance per manufacturer guidelines, they are intended for repeated use within clinical environments.
What types of sizes or configurations are available for the CareView 1800 RF X-ray Flat Panel Detectors, and how do I identify the correct model for my needs?
The CareView 1800 RF detectors come in multiple model variants, each corresponding to specific sizes or configurations. These are listed under registration numbers such as 3009717300, 3015223550, and others. To determine the correct model, refer to the manufacturer’s specifications or consult their technical documentation, as the exact dimensions or technical details are not provided in the regulatory data.
How should these detectors be stored and handled to ensure optimal performance and longevity?
The CareView 1800 RF X-ray Flat Panel Detectors require proper storage and handling as outlined in the manufacturer’s instructions. Since they are reusable and not sterile, adherence to cleaning and maintenance protocols is critical. Storage conditions must align with the manufacturer’s guidelines to preserve functionality and extend the device’s lifespan.
What regulatory pathways have these detectors undergone, and what does that mean for their use in clinical settings?
The CareView 1800 RF detectors have received FDA 510(k) clearance and MDR authorization, confirming they meet regulatory standards for safety and effectiveness. This classification as Class II devices under FDA regulations (892.1680) indicates they are subject to special controls for radiology applications, ensuring they are suitable for use in diagnostic imaging environments.
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: X-ray Flat Panel Detectors (CareView 1800 RF) (K221549) — FDA 510(k ..., Careray Digital X-Ray Flat Panel Detectors (CareView 1800…, CareRay Digital Medical Technologies - Radiography Solutions, X-ray Flat Panel Detectors (CareView 18... (K221549) - FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221549 | Class II | Active |
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Manufacturer
- Manufacturer
- Careray Digital Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K221549 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026