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Loop-X 1

by medPhoton GmbH

Ref P04-2

Loop-X 1 (P04-2) is a multi-modality diagnostic x-ray system (EU MDR Class IIb; FDA Class II; FDA product code OWB, Interventional Fluoroscopic X-Ray System) made by medPhoton GmbH, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 1912007532IRm33), cleared under FDA 510(k) K234067 on 28 Mar 2025 (1 earlier submission) and listed in FDA GUDID since 22 Mar 2021 (UDI-DI 19120075320075), active as of 23 Oct 2026.

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K234067

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1912007532IRm33 Basic UDI-DI Date10 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK234067 Date28 Mar 2025DecidedStatusActive
United StatesGUDID listing GUDID Number19120075320075 UDI-DI Date22 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 1912007532IRm33 registered 10 Jun 2026 Active
  • FDA 510(k) K234067 decided 28 Mar 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 19120075320075 listed 22 Mar 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K203281
  2. Listed FDA GUDID 19120075320075
  3. Cleared FDA 510(k) K234067
  4. Registered EUDAMED 1912007532IRm33

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  • Withdrawn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 · GUDID

Trade name
Loop-X
Generic name
Multi-modality diagnostic x-ray system, mobile
Device name
ImagingRing m
Model / Ref / Catalog
P04-2, 1, 2
Primary DI / UDI-DI
19120075320075, 19120075320129
Basic UDI-DI
1912007532IRm33
Direct marketing DI
19120075320075
19120075320129
510(k) Number
FDA product code
OWB
EMDN code
Z110312, Z11039009
GMDN term
Multi-modality diagnostic x-ray system, mobile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
P04-2
GUDID
1
2
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.

Related devices

Category: Multi-modality diagnostic x-ray system, mobile

Similar devices in this category

Other devices filed under FLUOROSCOPY DEVICES.

Other devices from medPhoton GmbH

  • ImagingRing r 1

    Class II

  • ImagingRing 1.2

    Class II

  • ImagingRing 1.1

    Class II

  • ImagingRing System

    Class II

See all devices from medPhoton GmbH →

Properties

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