Identifiers
- 510(k) Number
- K151942 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 3643 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for digital radiography. It converts X-ray exposure into digital signals, enabling high-resolution imaging for diagnostic purposes in radiology settings. The device integrates advanced flat-panel technology to provide real-time imaging capabilities, improving workflow efficiency and image quality for medical professionals.
This imager is supplied as a reusable medical device, intended for use in radiology departments and portable imaging applications. It operates in both wired and wireless configurations, with optional tethering for power supply, eliminating the need for a separate battery pack. The device adheres to regulatory standards, including FDA 510(k) clearance and MDR compliance, and is classified as a Class II medical device under the relevant nomenclature. Storage and handling follow standard sterile or non-sterile protocols for reusable imaging equipment, with specific safety guidelines outlined in manufacturer documentation.
Frequently asked questions
What types of medical settings is the EVS 3643 Solid State X-Ray Imager designed for, and how does its flexibility benefit users?
The EVS 3643 is specifically designed for radiology departments and portable imaging applications, making it suitable for both fixed and mobile use. Its ability to operate in both wired and wireless configurations—with optional tethering for power—eliminates the need for a separate battery pack, enhancing workflow efficiency and adaptability in various clinical environments.
Is the EVS 3643 a single-use or reusable device, and what does that mean for maintenance and cleaning?
The EVS 3643 is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it is not sterile out-of-the-box, it follows standard protocols for reusable imaging equipment, which include manufacturer-recommended cleaning procedures to ensure hygiene and longevity.
What regulatory pathways has the EVS 3643 followed, and how does this affect its use in clinical settings?
The EVS 3643 has undergone FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and performance. This classification as a Class II medical device ensures it adheres to stringent guidelines, providing confidence in its reliability and suitability for diagnostic radiography in clinical settings.
How does the EVS 3643’s flat-panel technology improve imaging quality compared to traditional systems?
The EVS 3643 integrates advanced flat-panel technology to convert X-ray exposure into high-resolution digital signals, enabling real-time imaging. This design enhances image clarity, reduces radiation dose, and improves workflow efficiency by providing immediate diagnostic-quality images for medical professionals.
What storage and handling guidelines should be followed for the EVS 3643 to maintain its performance and safety?
Since the EVS 3643 is reusable, it should be stored and handled according to standard protocols for non-sterile medical imaging equipment. Manufacturer documentation outlines specific safety guidelines, including environmental conditions and maintenance procedures, to ensure optimal performance and longevity of the device.
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: DRTECH EVS3643 Flat Panel Digital X-ray Detector User Manual EVS 3643, DRTECH EVS 3643 System User Manual and Safety Information, PDF DRTECH EVS 3643 / EVS 3643G - FCC ID Search, DRTECH, EVS3643 Flat Panel Digital X-ray Detector User Manual _EVS 3643 DRTECH
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 | K151942 | Class II | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
Sources (2)
- FDA 510(k) K151942 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026