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AeroDR X70 AACT

by Konica Minolta, Inc.

Model AeroDR X70

AeroDR X70 AACT is a device classified as Class IIb in the EU and Class II in the US made by Konica Minolta, Inc., registered in EUDAMED on 3 Jul 2026 (Basic UDI-DI B-04560141946231), cleared under FDA 510(k) K121109 on 23 May 2012 and listed in FDA GUDID since 15 Dec 2016 (UDI-DI 04560141946231), active as of 24 Oct 2026.

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

CE MDD 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) K121109

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/MDD EUDAMED NumberB-04560141946231 Basic UDI-DI 04560141946231UDI-DIDate3 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141946231 UDI-DI Date15 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121109 Date23 May 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04560141946231 registered 3 Jul 2026 Active
  • FDA 510(k) K121109 decided 23 May 2012 Active
  • FDA GUDID UDI-DI 04560141946231 listed 15 Dec 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K121109
  2. Listed FDA GUDID 04560141946231
  3. Registered EUDAMED B-04560141946231

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
AeroDR X70
Generic name
Stationary basic diagnostic x-ray system, digital
Model / reference
AeroDR X70 EUDAMED
AACT GUDID
Primary DI / UDI-DI
04560141946231
Basic UDI-DI
B-04560141946231
510(k) Number
FDA product code
KPR
EMDN code
Z11031101 Multifunctional systems for direct digital radiology
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AeroDR X70
GUDID
AACT
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: Stationary basic diagnostic x-ray system, digital

Cleared under the same submission (K121109)

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (21, all answered No)