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Evs 3643

by DRTECH Corporation

510(k) K151942

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) K151942↗

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 NumberK151942 Date21 Oct 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151942 decided 21 Oct 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  • Withdrawn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 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.

Similar devices

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

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