Skip to content

GC85A Digital Diagnostic X-ray System

by Samsung Electronics Co., Ltd

Ref GC85A

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

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182183

+4 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8806090DGRGC001VD Basic UDI-DI 08806088565231UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182183 Date7 Dec 2018DecidedStatusActive
United StatesFDA 510(k) 510(k) NumberK181629 Date20 Jul 2018IssuedStatusActive
United StatesGUDID listing GUDID Number08806088565231 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8806090DGRGC001VD registered 21 Apr 2026 Active
  • FDA 510(k) K182183 decided 7 Dec 2018 Active· +4 more in the status table
  • FDA GUDID UDI-DI 08806088565231 listed 24 Sep 2016 Listed

Timeline

7 dated events

  1. Cleared FDA 510(k) K150165
  2. Cleared FDA 510(k) K160997
  3. Listed FDA GUDID 08806088565231
  4. Cleared FDA 510(k) K172229
  5. Cleared FDA 510(k) K181629
  6. Cleared FDA 510(k) K182183
  7. Registered EUDAMED 8806090DGRGC001VD

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Full name
GC85A
Generic name
Stationary basic diagnostic x-ray system, digital
Model / reference
GC85A
Primary DI / UDI-DI
08806088565231
Basic UDI-DI
8806090DGRGC001VD
510(k) Number
FDA product code
KPR, MQB
EMDN code
Z11031101 Multifunctional systems for direct digital radiology
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
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 GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000020682
Authorised representative
Samsung Electronics GmbH DE-AR-000007005

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 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.

Related devices

Category: Stationary basic diagnostic x-ray system, digital

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)