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G-59 AE81

by Konica Minolta, Inc.

Part of a family of 35 devices: see the family page

Ref AE81Model SKR 3000, accessories

G-59 AE81 is a device classified as Class I in the EU and Class II in the US made by Konica Minolta, Inc., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 4560141920001078C), cleared under FDA 510(k) K223267 on 17 Nov 2022 and listed in FDA GUDID since 14 Jun 2023 (UDI-DI 04560141950771), 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) K223267

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 Number4560141920001078C Basic UDI-DI 04560141950771UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141950771 UDI-DI Date14 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK223267 Date17 Nov 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4560141920001078C registered 2 Jul 2026 Active
  • FDA 510(k) K223267 decided 17 Nov 2022 Active
  • FDA GUDID UDI-DI 04560141950771 listed 14 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223267
  2. Listed FDA GUDID 04560141950771
  3. Registered EUDAMED 4560141920001078C

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  • Withdrawn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
G-59
Generic name
Flat panel x-ray detector integration unit
Model / reference
AE81, SKR 3000, accessories
Primary DI / UDI-DI
04560141950771
Basic UDI-DI
4560141920001078C
Direct marketing DI
04560141950771
510(k) Number
FDA product code
MQB
EMDN code
Z11031180 Systems for direct digital radiology (dr) - hardware accessories
GMDN term
Flat panel x-ray detector integration unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1680
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Flat panel x-ray detector integration unit

Cleared under the same submission (K223267)

and 2 more cleared under K223267

Similar devices in this category

Other devices filed under SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES.

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)