# GM85

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

- Canonical page: <https://devicerts.com/devices/gm85-izl>
- Manufacturer: [Samsung Electronics Co., Ltd.](https://devicerts.com/manufacturers/samsung-electronics-coltd-kr-mf-000020682) (South Korea)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: IZL, MQB, KPR
- EMDN: Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
- GMDN: Mobile basic diagnostic x-ray system, digital (37647)

## 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 GM85 is a Mobile X-Ray System (OpenFDA classification: IZL) designed for portable radiographic imaging. It generates X-ray images by transmitting ionizing radiation through a patient’s body, capturing the resulting signals via detectors and converting them into digital data for diagnostic evaluation. The system is configured for versatile radiographic applications, including general radiography and specialized imaging in mobile settings.

The GM85 is supplied as a reusable, non-sterile device intended for use in clinical radiology departments, emergency settings, or mobile imaging units. It features optional configurations, such as a collapsible column type with manual collimation, multiple detector options, and wired/wireless exposure switches. The system operates under FDA 510(k) clearance (K220175, K222353) and EU MDR compliance, with no MRI safety restrictions. Storage and handling follow standard radiographic equipment protocols.

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 8806090DGRGM001XK · UDI-DI 08806088582412 · registered 2026-04-21 · status: Active
- **GUDID** · FDA 510(k) · United States · K222353 · decision 2022-09-29 · decision SESE · status: Active · from GUDID
- **510(k)** · FDA 510(k) · United States · K220175 · decision 2022-04-21 · decision SESE · status: Active
- **GUDID** · FDA 510(k) · United States · K182183 · decision 2018-12-07 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K181626 · decision 2018-07-20 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K180543 · decision 2018-05-24 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K171119 · decision 2017-05-12 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 08806088582412 · listed 2016-11-26 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K162278 · decision 2016-11-15 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0480-2026 · Class II · ongoing · initiated 2025-10-07: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
- Z-1056-2024 · Class II · ongoing · initiated 2023-12-28: Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
- Z-1414-2023 · Class II · ongoing · initiated 2023-03-08: Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
- Z-1691-2019 · Class II · terminated · initiated 2019-05-06: Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.

## Identity

- Generic name: Mobile basic diagnostic x-ray system, digital [FDA GUDID (AccessGUDID)]
- Device name: Digital Diagnostic Mobile X-ray System [EUDAMED]
- Model / reference: GM85 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08806088582412 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 8806090DGRGM001XK [EUDAMED]
- 510(k) Number: K220175 [FDA 510(k), FDA GUDID (AccessGUDID)]; K162278 [FDA GUDID (AccessGUDID)]; K171119 [FDA GUDID (AccessGUDID)]; K180543 [FDA GUDID (AccessGUDID)]; K181626 [FDA GUDID (AccessGUDID)]; K182183 [FDA GUDID (AccessGUDID)]; K222353 [FDA GUDID (AccessGUDID)]
- FDA product code: IZL [FDA 510(k), FDA GUDID (AccessGUDID)]; MQB [FDA GUDID (AccessGUDID)]
- EMDN code: Z11031101 [EUDAMED]
- GMDN term: Mobile basic diagnostic x-ray system, digital (37647) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 892.1720 [FDA 510(k), FDA GUDID (AccessGUDID)]; 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: Finland [EUDAMED]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- 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: GM85, Samsung Electronics Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/gm85-izl (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), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/gm85-izl.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/gm85-izl
- 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.