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Evs 4343

by DRTECH Corporation

510(k) K142475

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142475↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142475 Date15 Jan 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142475 decided 15 Jan 2015 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MQB
Device class
Class II
Regulation
21 CFR Part 892.1680
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

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