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P-85 ADU2

by Konica Minolta, Inc.

Ref ADU2Model SKR 3000, P-85

P-85 ADU2 is an indirect flat panel x-ray detector (EU MDR Class IIa; FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by Konica Minolta, Inc., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 45601419200010486), cleared under FDA 510(k) K213908 on 31 Jan 2022 and listed in FDA GUDID since 11 Mar 2022 (UDI-DI 04560141950283), 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) K213908

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 Number45601419200010486 Basic UDI-DI 04560141950283UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141950283 UDI-DI Date11 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213908 Date31 Jan 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 45601419200010486 registered 2 Jul 2026 Active
  • FDA 510(k) K213908 decided 31 Jan 2022 Active
  • FDA GUDID UDI-DI 04560141950283 listed 11 Mar 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213908
  2. Listed FDA GUDID 04560141950283
  3. Registered EUDAMED 45601419200010486

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  • Withdrawn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
P-85
Generic name
Indirect flat panel x-ray detector
Model / reference
ADU2, SKR 3000, P-85
Primary DI / UDI-DI
04560141950283
Basic UDI-DI
45601419200010486
Direct marketing DI
04560141950283
510(k) Number
FDA product code
MQB
EMDN code
Z11031102 Direct digital teleradiographs
GMDN term
Indirect flat panel x-ray detector
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1680
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Indirect flat panel x-ray detector

Cleared under the same submission (K213908)

and 1 more cleared under K213908

Similar devices in this category

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

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

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