Evs 4343a, Evs 4343ag, Evs 3643a, Evs 3643ag
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192400 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 EVS 4343A, EVS 4343AG, EVS 3643A, and EVS 3643AG are Solid State X-Ray Imagers (Flat Panel/Digital Imagers). These devices convert X-ray exposure into digital signals, enabling high-resolution radiographic imaging for diagnostic radiology applications. They are designed to replace traditional film-based systems, providing immediate digital output for enhanced workflow efficiency and image quality.
These imagers are intended for use in radiology settings and are supplied as reusable devices. They are classified as Class II medical devices under FDA regulations and have received FDA 510(k) clearance and MDR authorization. The devices are not specified as single-use or sterile, and their MRI safety classification is not detailed in the provided data. Storage and handling instructions are not included, but they are regulated under 21 CFR 892.1680 and fall under the MQB product code category.
Frequently asked questions
Are these devices intended for single-use or can they be reused in a clinical setting?
The EVS 4343A, EVS 4343AG, EVS 3643A, and EVS 3643AG are explicitly described as reusable devices. Since they are classified as Class II medical devices and lack any mention of single-use or sterility requirements, they are designed for repeated use in radiology settings after proper cleaning and maintenance.
What types of sizes or models are available for these Solid State X-Ray Imagers, and how do they differ?
The device family includes four models: EVS 4343A, EVS 4343AG, EVS 3643A, and EVS 3643AG. While the exact size differences (e.g., detector dimensions or field of view) are not detailed in the provided data, the numeric distinctions in the model names (e.g., 4343 vs. 3643) likely correspond to variations in imaging area or technical specifications. For precise sizing, refer to the manufacturer’s technical documentation.
How are these devices regulated, and what regulatory pathways have they followed?
These devices have undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming compliance with both U.S. and EU regulatory requirements. They fall under 21 CFR 892.1680 and are classified as Class II under FDA regulations. The MQB product code categorizes them for administrative filing purposes, but this does not define their clinical use.
Are there any specific storage or handling instructions provided for these imagers?
The provided data does not include explicit storage or handling instructions for the EVS series imagers. Since they are reusable, proper cleaning, maintenance, and environmental conditions (e.g., temperature, humidity) should follow manufacturer guidelines to ensure longevity and performance. Always consult the manufacturer’s instructions for detailed protocols.
What is the primary advantage of using these digital imagers over traditional film-based systems?
The EVS imagers are designed to replace traditional film-based systems by converting X-ray exposure into high-resolution digital signals, enabling immediate digital output. This eliminates the need for chemical processing, reduces workflow delays, and enhances image quality and accessibility for diagnostic radiology 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.
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 | K192400 | Class II | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
Sources (2)
- FDA 510(k) K192400 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026