Identifiers
- 510(k) Number
- K142475 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 4343 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), a digital radiography device designed to capture high-resolution radiographic images for diagnostic purposes. It converts X-ray exposure into digital signals, enabling real-time imaging and enhancing diagnostic accuracy in radiology settings. This technology supports a range of medical imaging applications, including fluoroscopy and general radiography, by providing clear, detailed visualizations of internal structures.
This device is supplied as a reusable medical instrument, intended for use in controlled clinical environments such as hospitals and diagnostic imaging centers. It adheres to FDA 510K and MDR regulatory standards, with a classification under Device Class II (per OpenFDA). The imager operates within standard MRI safety guidelines for non-MRI environments and requires proper calibration and maintenance to ensure consistent performance. Storage and handling follow manufacturer guidelines to preserve functionality and sterility where applicable.
Frequently asked questions
What types of medical imaging procedures can the EVS 4343 be used for in a clinical setting?
The EVS 4343 is designed for digital radiography applications, including fluoroscopy and general radiography. Its solid-state X-ray imager captures high-resolution images of internal structures, making it suitable for diagnostic purposes in radiology settings like hospitals and imaging centers. The device enhances diagnostic accuracy by providing real-time imaging and clear visualizations.
Is the EVS 4343 a single-use or reusable device, and what does that mean for maintenance?
The EVS 4343 is a reusable medical instrument, meaning it is intended for repeated use in controlled clinical environments. Since it is reusable, proper calibration and maintenance are required to ensure consistent performance and reliability over time. The manufacturer provides guidelines for storage and handling to preserve functionality.
What regulatory pathways has the EVS 4343 followed, and what does that indicate about its approval status?
The EVS 4343 has undergone FDA 510(k) clearance and adheres to the EU Medical Device Regulation (MDR). It is classified as a Device Class II under OpenFDA, indicating it has been deemed substantially equivalent to a predicate device through the traditional 510(k) review process. This classification reflects its regulatory evaluation but does not imply specific clinical indications—only that it meets safety and performance standards for its intended use in radiology.
How should the EVS 4343 be stored to maintain its functionality and safety?
The EVS 4343 requires adherence to manufacturer-provided guidelines for storage and handling to preserve its functionality and ensure safety. Since it is a reusable device, proper environmental controls and maintenance protocols are critical. The manufacturer’s instructions should be followed to avoid damage, contamination, or performance degradation, particularly in controlled clinical settings like hospitals or imaging centers.
What safety considerations should be taken into account when using the EVS 4343 near MRI environments?
The EVS 4343 operates within standard MRI safety guidelines for non-MRI environments, meaning it is not designed for use inside an MRI scanner. However, its placement in areas where MRI equipment is present requires careful attention to electromagnetic interference and safety protocols to prevent potential risks. Always follow facility-specific guidelines for equipment compatibility and safety.
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 | K142475 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DRTECH Corporation
Sources (2)
- FDA 510(k) K142475 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026