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EConsole1

by Drtech Corp.

Ref EConsole1

EConsole1 is a device classified as Class IIb in the EU and Class II in the US made by Drtech Corp., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 88000184PGXXXXXXXX4U), cleared under FDA 510(k) K231225 on 18 Oct 2023 and listed in FDA GUDID since 2 Sep 2016 (UDI-DI 08800018410004), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231225

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000184PGXXXXXXXX4U Basic UDI-DI 08800018410004UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231225 Date18 Oct 2023DecidedStatusActive
United StatesGUDID listing GUDID Number08800018410004 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000184PGXXXXXXXX4U registered 23 Jul 2026 Active
  • FDA 510(k) K231225 decided 18 Oct 2023 Active
  • FDA GUDID UDI-DI 08800018410004 listed 2 Sep 2016 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 08800018410004
  2. Cleared FDA 510(k) K231225
  3. Registered EUDAMED 88000184PGXXXXXXXX4U

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  • Withdrawn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 · GUDID

Generic name
Radiology DICOM image processing application software
Device name
Radiological Image Processing System
Model / reference
EConsole1
Primary DI / UDI-DI
08800018410004
Basic UDI-DI
88000184PGXXXXXXXX4U
Direct marketing DI
08800018410004
510(k) Number
FDA product code
LLZ
EMDN code
Z11031192 Systems for direct digital radiology (dr) - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiology DICOM image processing application software

Similar devices in this category

Other devices filed under DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS.

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)