# Port-X IV

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/port-x-iv-ehd>
- Manufacturer: [Genoray Co., Ltd.](https://devicerts.com/manufacturers/genoray-co-ltd) (South Korea)
- Name in the registry: PORT-X IV
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: EHD
- EMDN: Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY
- GMDN: Portable basic diagnostic x-ray system, digital (37643)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data 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.

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-08809244061202 · UDI-DI 08809244061202 · registered 2026-05-29 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08809244061202 · listed 2018-04-11 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K172810 · decision 2018-03-07 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: Genoray [FDA GUDID (AccessGUDID)]
- Generic name: Portable basic diagnostic x-ray system, digital [FDA GUDID (AccessGUDID)]
- Model / reference: 206 [EUDAMED]; PORT-X IV [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08809244061202 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-08809244061202 [EUDAMED]
- 510(k) Number: K172810 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: EHD [FDA 510(k), FDA GUDID (AccessGUDID)]
- EMDN code: Z1103040101 [EUDAMED]
- GMDN term: Portable basic diagnostic x-ray system, digital (37643) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 872.1800 [FDA 510(k), FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- Advisory committee: Dental [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Port-X IV, Genoray Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/port-x-iv-ehd (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/port-x-iv-ehd.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/port-x-iv-ehd
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.