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RConsole1 1.0

by Drtech Corp.

Ref RConsole1

RConsole1 1.0 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 88000184PMXXXXXXXX96), cleared under FDA 510(k) K162670 on 23 Feb 2017 and listed in FDA GUDID since 4 Aug 2017 (UDI-DI 08800018411001), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162670

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000184PMXXXXXXXX96 Basic UDI-DI 08800018411001UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800018411001 UDI-DI Date4 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162670 Date23 Feb 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000184PMXXXXXXXX96 registered 23 Jul 2026 Active
  • FDA 510(k) K162670 decided 23 Feb 2017 Active
  • FDA GUDID UDI-DI 08800018411001 listed 4 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162670
  2. Listed FDA GUDID 08800018411001
  3. Registered EUDAMED 88000184PMXXXXXXXX96

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  • Withdrawn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

Trade name
RConsole1
Generic name
Radiology DICOM image processing application software
Device name
Radiological Image Processing System
Model / reference
RConsole1 EUDAMED
1.0 GUDID
Primary DI / UDI-DI
08800018411001
Basic UDI-DI
88000184PMXXXXXXXX96
Direct marketing DI
08800018411001
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RConsole1
GUDID
1.0
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

Cleared under the same submission (K162670)

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

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)