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Promo Mobile X-Ray System

by DRGEM Corporation

510(k) K251443Ref PROMO

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251443↗

FDA record

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 Number88000111DMP5000ZP Basic UDI-DI Date20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800011150105 UDI-DI Date26 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK251443 Date22 Aug 2025ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000111DMP5000ZP registered 20 May 2026 Active
  • FDA 510(k) K251443 decided 22 Aug 2025 Active
  • FDA GUDID UDI-DI 08800011150105 listed 26 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K251443
  2. Listed FDA GUDID 08800011150105
  3. Registered EUDAMED 88000111DMP5000ZP

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  • Withdrawn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

Full name
Promo
Trade name
Promo EUDAMED
Drgem GUDID
Generic name
Mobile basic diagnostic x-ray system, digital
Model / reference
PROMO
Primary DI / UDI-DI
08800011150105, 08800011150112, 08800011151003, 08800011151010
Basic UDI-DI
88000111DMP5000ZP
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
EU registration type
Standard device
EU market of registration
Türkiye
Poland
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

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 Promo Mobile X-Ray System is a portable radiographic imaging device designed for mobile radiography applications. It generates high-quality X-ray images for diagnostic purposes, supporting flexible positioning and stable mobility to enhance workflow efficiency in various clinical settings.

This system is intended for single-use or reusable applications, depending on the configuration, and is regulated under FDA 510(k) clearance and MDR compliance. It operates within Class II medical device classification and is intended for use in radiology departments, emergency settings, and other mobile imaging scenarios. The device is supplied with multiple FEI numbers and registration identifiers, ensuring traceability and adherence to regulatory standards.

Devices cleared under K251443

2 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 K251443
UDI-DISize and differences
DRGEM PROMO
DRGEM Corporation
PROMO08800011150112 —On the market
DRGEM PROMO
DRGEM Corporation
PROMO08800011150105 —On the market

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

Other devices from DRGEM Corporation

See all devices from DRGEM Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)