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REGIUS Cassette A3P5

by Konica Minolta, Inc.

Part of a family of 8 devices: see the family page

Ref RC-300 10×12: A3P5Model RC-300

REGIUS Cassette A3P5 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 45601419200004289), cleared under FDA 510(k) K103703 on 2 Jun 2011 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141933231), 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) K103703

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 Number45601419200004289 Basic UDI-DI 04560141933231UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141933231 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103703 Date2 Jun 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 45601419200004289 registered 2 Jul 2026 Active
  • FDA 510(k) K103703 decided 2 Jun 2011 Active
  • FDA GUDID UDI-DI 04560141933231 listed 19 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103703
  2. Listed FDA GUDID 04560141933231
  3. Registered EUDAMED 45601419200004289

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  • Withdrawn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
REGIUS Cassette
Generic name
Digital imaging cassette
Model / reference
RC-300 EUDAMED
RC-300 10×12: A3P5 EUDAMED
A3P5 GUDID
Primary DI / UDI-DI
04560141933231
Basic UDI-DI
45601419200004289
Direct marketing DI
04560141933231
510(k) Number
FDA product code
MQB
EMDN code
Z11060280 Digital computed radiography (cr) systems - hardware accessories
GMDN term
Digital imaging cassette
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
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RC-300
RC-300 10×12: A3P5
GUDID
A3P5
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: Digital imaging cassette

Cleared under the same submission (K103703)

and 5 more cleared under K103703

Similar devices in this category

Other devices filed under DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - 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)