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GM85

by Samsung Electronics Co., Ltd.

510(k) K220175Ref GM85

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222353

+6 more

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8806090DGRGM001XK Basic UDI-DI 08806088582412UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222353 Date29 Sep 2022DecidedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK220175 Date21 Apr 2022ClearedStatusActive
United StatesGUDID listing GUDID Number08806088582412 UDI-DI Date26 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8806090DGRGM001XK registered 21 Apr 2026 Active
  • FDA 510(k) K222353 decided 29 Sep 2022 Active· +6 more in the status table
  • FDA GUDID UDI-DI 08806088582412 listed 26 Nov 2016 Listed

Recalls

4 recalls · 3 ongoing · FDA

    • Ongoing Z-0480-2026 FDA Class II initiated 7 Oct 2025

    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.

    • Ongoing Z-1056-2024 FDA Class II initiated 28 Dec 2023

    Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.

    • Ongoing Z-1414-2023 FDA Class II initiated 8 Mar 2023

    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

    • Terminated Z-1691-2019 FDA Class II initiated 6 May 2019

    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.

Timeline

13 dated events

  1. Cleared FDA 510(k) K180543
  2. Cleared FDA 510(k) K181626
  3. Cleared FDA 510(k) K182183
  4. Recall initiated FDA recalls Z-1691-2019
  5. Cleared FDA 510(k) K220175
  6. Cleared FDA 510(k) K222353
  7. Recall initiated FDA recalls Z-1414-2023
  8. Recall initiated FDA recalls Z-1056-2024
  9. Recall initiated FDA recalls Z-0480-2026
  10. Registered EUDAMED 8806090DGRGM001XK

3 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Mobile basic diagnostic x-ray system, digital
Device name
Digital Diagnostic Mobile X-ray System
Model / reference
GM85
Primary DI / UDI-DI
08806088582412
Basic UDI-DI
8806090DGRGM001XK
510(k) Number
FDA product code
IZL, MQB
EMDN code
Z11031101 Multifunctional systems for direct digital radiology
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1720 510(k)GUDID
892.1680 GUDID
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Finland
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
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 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.

Devices cleared under K220175

3 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 K220175
UDI-DISize and differences
GM85
Samsung Electronics Co., Ltd.
GM8508806088582412 —On the market
S4335-AWM
Samsung Electronics Co., Ltd.
S4335-AWM08806094458213 —On the market
S4343-AWM
Samsung Electronics Co., Ltd.
S4343-AWM08806094458220 —On the market

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

Other devices from Samsung Electronics Co., Ltd

See all devices from Samsung Electronics Co., Ltd →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)