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Dx-D 300 8207/050

by Agfa Corp.

Ref 5NBXP

Dx-D 300 8207/050 (5NBXP) is a device classified as Class IIb in the EU and Class II in the US made by Agfa Corp., registered in EUDAMED on 28 Aug 2024 (Basic UDI-DI 5414904272718YK) with CE/MDR certificate 28620125060 valid until 31 May 2027, cleared under FDA 510(k) K103050 on 29 Oct 2010 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904079607), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

31 May 2027

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K103050

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414904272718YK Basic UDI-DI 05414904079607UDI-DIDate28 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05414904079607 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103050 Date29 Oct 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414904272718YK registered 28 Aug 2024 Active· +1 more in the status table
  • FDA 510(k) K103050 decided 29 Oct 2010 Active
  • FDA GUDID UDI-DI 05414904079607 listed 1 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620125060 Expiring Supplemented Expires in 199 days

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    14 Sep 2023
    Expires
    31 May 2027
    Reason
    Add device or group

Timeline

5 dated events

  1. Cleared FDA 510(k) K103050
  2. Listed FDA GUDID 05414904079607
  3. Certificate issued EUDAMED 28620125060
  4. Registered EUDAMED 5414904272718YK
  5. Certificate expires EUDAMED 28620125060

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Dx-D 300
Generic name
Stationary basic diagnostic x-ray system, digital
Device name
Dx-D 300 8207
Model / Ref / Catalog
5NBXP, 8207/050
Primary DI / UDI-DI
05414904079607
Basic UDI-DI
5414904272718YK
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
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5NBXP
GUDID
8207/050
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

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

Other devices from Agfa Corp.

See all devices from Agfa Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)