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Genoray ZEN-PX4

by Genoray Co., Ltd.

Ref 206

Genoray ZEN-PX4 is a device classified as Class IIb in the EU and Class II in the US made by Genoray Co., Ltd., registered in EUDAMED on 29 May 2026 (Basic UDI-DI B-08809244061226), cleared under FDA 510(k) K172810 on 7 Mar 2018 and listed in FDA GUDID since 11 Apr 2018 (UDI-DI 08809244061226), 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) K172810

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-08809244061226 Basic UDI-DI 08809244061226UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809244061226 UDI-DI Date11 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172810 Date7 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809244061226 registered 29 May 2026 Active
  • FDA 510(k) K172810 decided 7 Mar 2018 Active
  • FDA GUDID UDI-DI 08809244061226 listed 11 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172810
  2. Listed FDA GUDID 08809244061226
  3. Registered EUDAMED B-08809244061226

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  • Withdrawn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
Genoray
Generic name
Portable basic diagnostic x-ray system, digital
Device name
Zen-PX4
Model / reference
206 EUDAMED
ZEN-PX4 GUDID
Primary DI / UDI-DI
08809244061226
Basic UDI-DI
B-08809244061226
510(k) Number
FDA product code
EHD
EMDN code
Z1103040101 Equipment for conventional endoral radiology
GMDN term
Portable basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
206
GUDID
ZEN-PX4
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: Portable basic diagnostic x-ray system, digital

Cleared under the same submission (K172810)

Similar devices in this category

Other devices filed under EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY.

Other devices from Genoray Co., Ltd.

  • Genoray GT300

    Class II

  • Genoray GT300-C

    Class II

  • Genoray VETERA DM

    Class II

  • Genoray VETERA ACE

    Class II

See all devices from Genoray Co., Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)