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Port-X IV

by Genoray Co., Ltd.

510(k) K172810Ref 206

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172810↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809244061202 Basic UDI-DI 08809244061202UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809244061202 UDI-DI Date11 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK172810 Date7 Mar 2018ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809244061202 registered 29 May 2026 Active
  • FDA 510(k) K172810 decided 7 Mar 2018 Active
  • FDA GUDID UDI-DI 08809244061202 listed 11 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172810
  2. Listed FDA GUDID 08809244061202
  3. Registered EUDAMED B-08809244061202

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  • Withdrawn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 · 510(k) · GUDID

Trade name
Genoray
Generic name
Portable basic diagnostic x-ray system, digital
Model / reference
206 EUDAMED
PORT-X IV GUDID
Primary DI / UDI-DI
08809244061202
Basic UDI-DI
B-08809244061202
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 510(k)GUDID
Regulation
21 CFR Part 872.1800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / referenceEUDAMED
206
510(k)
—
GUDID
PORT-X IV
Device classEUDAMED
Class IIb
510(k)
Class II
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 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Port-X IV is an extraoral dental X-ray unit with an integrated timer, designed for capturing high-quality radiographic images of dental structures. Classified as a Class II device under FDA regulations, it is intended for use in dental diagnostics, providing precise imaging for oral health assessments.

This portable device is powered by a rechargeable battery, enabling up to 400 exposures per full charge with a 0.5-second exposure time. Supplied as a reusable medical device, it adheres to the Medical Device Directive (MDD) and is regulated under FDA 510(k) clearance for dental applications. Storage and handling follow standard radiographic safety protocols to ensure optimal performance and compliance with regulatory standards.

Devices cleared under K172810

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K172810
UDI-DISize and differences
Genoray PORT-X IV
GENORAY CO., LTD.
PORT-X IV08809244061202 —On the market
Genoray VETERA PE
GENORAY CO., LTD.
VETERA PE08809244060670 —On the market
Genoray VETERA PX
GENORAY CO., LTD.
VETERA PX08809244060663 —On the market
Genoray ZEN-PX4
GENORAY CO., LTD.
ZEN-PX408809244061226 —On the market

Similar devices in this category

Other devices filed under EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY.

Other devices from Genoray Co., Ltd.

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    Class II

  • Genoray GT300-C

    Class II

  • Genoray VETERA DM

    Class II

  • Genoray VETERA ACE

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See all devices from Genoray Co., Ltd. →

Properties

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