# GC85A Digital Diagnostic X-ray System

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

- Canonical page: <https://devicerts.com/devices/gc85a-gc85a>
- Manufacturer: [Samsung Electronics Co., Ltd](https://devicerts.com/manufacturers/samsung-electronics-coltd-kr-mf-000020682) (South Korea)
- Name in the registry: GC85A
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: KPR, MQB
- EMDN: Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
- GMDN: Stationary basic diagnostic x-ray system, digital (37645)

## 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 GC85A is a Digital Diagnostic X-ray System, classified under nomenclature code Z11031101. This device generates radiographic images for diagnostic purposes, enabling visualisation of internal body structures such as bones, organs, and tissues through controlled X-ray exposure. It operates as a Class IIb medical device, adhering to stringent safety and performance standards for imaging applications.

The GC85A is a non-sterile, non-reusable system designed for use in clinical settings such as hospitals, diagnostic centres, and radiology departments. Supplied as a single-use component-free unit, it requires proper calibration and maintenance as specified by the manufacturer. The device is authorised under FDA 510K and MDR compliance, ensuring adherence to regulatory requirements for diagnostic imaging equipment. Storage and operational conditions must follow manufacturer guidelines to preserve functionality and image quality.

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 8806090DGRGC001VD · UDI-DI 08806088565231 · registered 2026-04-21 · status: Active
- **GUDID** · FDA 510(k) · United States · K182183 · decision 2018-12-07 · decision SESE · status: Active · from GUDID
- **510(k)** · FDA 510(k) · United States · K181629 · issued 2018-07-20 · status: Active
- **510(k)** · FDA 510(k) · United States · K172229 · issued 2017-11-22 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08806088565231 · listed 2016-09-24 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K160997 · issued 2016-07-06 · status: Active
- **510(k)** · FDA 510(k) · United States · K150165 · issued 2015-04-02 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Stationary basic diagnostic x-ray system, digital [FDA GUDID (AccessGUDID)]
- Model / reference: GC85A [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08806088565231 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 8806090DGRGC001VD [EUDAMED]
- 510(k) Number: K150165 [FDA GUDID (AccessGUDID)]; K160997 [FDA GUDID (AccessGUDID)]; K172229 [FDA GUDID (AccessGUDID)]; K181629 [FDA GUDID (AccessGUDID)]; K182183 [FDA GUDID (AccessGUDID)]
- FDA product code: KPR [FDA GUDID (AccessGUDID)]; MQB [FDA GUDID (AccessGUDID)]
- EMDN code: Z11031101 [EUDAMED]
- GMDN term: Stationary basic diagnostic x-ray system, digital (37645) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.1680 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Sweden [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: 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]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): 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]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: GC85A Digital Diagnostic X-ray System, Samsung Electronics Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/gc85a-gc85a (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/gc85a-gc85a.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/gc85a-gc85a
- 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.