Skip to content

Regius Model SIGMA2 A5ER

by Konica Minolta, Inc.

Model REGIUS SIGMA2

Regius Model SIGMA2 A5ER 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 3 Jul 2026 (Basic UDI-DI B-04560141936379), cleared under FDA 510(k) K120131 on 10 Feb 2012 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141936379), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120131

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/MDD EUDAMED NumberB-04560141936379 Basic UDI-DI 04560141936379UDI-DIDate3 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141936379 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK120131 Date10 Feb 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04560141936379 registered 3 Jul 2026 Active
  • FDA 510(k) K120131 decided 10 Feb 2012 Active
  • FDA GUDID UDI-DI 04560141936379 listed 19 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120131
  2. Listed FDA GUDID 04560141936379
  3. Registered EUDAMED B-04560141936379

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  • Withdrawn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
Regius Model SIGMA2
Generic name
Computed radiography digital imaging scanner
Model / reference
REGIUS SIGMA2 EUDAMED
A5ER GUDID
Primary DI / UDI-DI
04560141936379
Basic UDI-DI
B-04560141936379
510(k) Number
FDA product code
MQB
EMDN code
Z11060201 Single-input computed radiography (cr) systems
GMDN term
Computed radiography digital imaging scanner
Device class
Class IIa 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
REGIUS SIGMA2
GUDID
A5ER
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: Computed radiography digital imaging scanner

Cleared under the same submission (K120131)

Similar devices in this category

Other devices filed under SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS.

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

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