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REGIUS Plate P49C

by Konica Minolta, Inc.

Ref P49CModel RP6M110

REGIUS Plate P49C 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 9 Jul 2026 (Basic UDI-DI B-04560141931107), cleared under FDA 510(k) K092717 on 30 Oct 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141931107), 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) K092717

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-04560141931107 Basic UDI-DI 04560141931107UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141931107 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK092717 Date30 Oct 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04560141931107 registered 9 Jul 2026 Active
  • FDA 510(k) K092717 decided 30 Oct 2009 Active
  • FDA GUDID UDI-DI 04560141931107 listed 19 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K092717
  2. Listed FDA GUDID 04560141931107
  3. Registered EUDAMED B-04560141931107

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  • Withdrawn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 Plate
Generic name
Digital imaging storage phosphor screen
Device name
P49C
Model / reference
P49C, RP6M110
Primary DI / UDI-DI
04560141931107
Basic UDI-DI
B-04560141931107
510(k) Number
FDA product code
MQB
EMDN code
Z11060280 Digital computed radiography (cr) systems - hardware accessories
GMDN term
Digital imaging storage phosphor screen
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 · 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: Digital imaging storage phosphor screen

Cleared under the same submission (K092717)

and 8 more cleared under K092717

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 (21, all answered No)