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Cr MD4.0R General Set 18X24

by Agfa Corp.

Ref E493N

Cr MD4.0R General Set 18X24 (E493N) is a device classified as Class IIa in the EU and Class II in the US made by Agfa Corp., registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI B-05414904026793), cleared under FDA 510(k) K141602 on 12 Sep 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904026793), 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) K141602

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-05414904026793 Basic UDI-DI 05414904026793UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414904026793 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141602 Date12 Sep 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05414904026793 registered 13 Aug 2026 Active
  • FDA 510(k) K141602 decided 12 Sep 2014 Active
  • FDA GUDID UDI-DI 05414904026793 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141602
  2. Listed FDA GUDID 05414904026793
  3. Registered EUDAMED B-05414904026793

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  • Withdrawn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
Cr MD4.0R General (Sr) Set EUDAMED
Cr MD4.0R General Set GUDID
Generic name
Digital imaging cassette/phosphor plate
Device name
Cr: HD5.0, HM5.0, MD4.0R
Model / Ref / Catalog
E493N, CR MD4.0R GENERAL SET 18X24
Primary DI / UDI-DI
05414904026793
Basic UDI-DI
B-05414904026793
510(k) Number
FDA product code
MQB
EMDN code
Z11060280 Digital computed radiography (cr) systems - hardware accessories
GMDN term
Digital imaging cassette/phosphor plate
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1680
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 18 Centimeter
Width — 24 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
E493N
GUDID
CR MD4.0R GENERAL SET 18X24
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 cassette/phosphor plate

Cleared under the same submission (K141602)

and 8 more cleared under K141602

Similar devices in this category

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

Other devices from Agfa Corp.

See all devices from Agfa Corp. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)