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P-81 A8CG

by Konica Minolta, Inc.

Ref A8CGModel SKR 3000

P-81 A8CG is a device classified as Class IIa in the EU and Class II in the US made by Konica Minolta, Inc., registered in EUDAMED on 7 May 2025 (Basic UDI-DI 4560141920001017Y), cleared under FDA 510(k) K172793 on 12 Oct 2017 and listed in FDA GUDID since 25 Jan 2018 (UDI-DI 04560141945777), 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) K172793

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 Number4560141920001017Y Basic UDI-DI 04560141945777UDI-DIDate7 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141945777 UDI-DI Date25 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK172793 Date12 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4560141920001017Y registered 7 May 2025 Active
  • FDA 510(k) K172793 decided 12 Oct 2017 Active
  • FDA GUDID UDI-DI 04560141945777 listed 25 Jan 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172793
  2. Listed FDA GUDID 04560141945777
  3. Registered EUDAMED 4560141920001017Y

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  • Withdrawn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-81
Generic name
Indirect flat panel x-ray detector
Model / reference
A8CG, SKR 3000
Primary DI / UDI-DI
04560141945777
Basic UDI-DI
4560141920001017Y
Direct marketing DI
04560141945777
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 (K172793)

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)