# Loop-X 1

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

- Canonical page: <https://devicerts.com/devices/loop-x-p04-2>
- Manufacturer: [medPhoton GmbH](https://devicerts.com/manufacturers/medphoton-gmbh) (Austria)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: OWB
- EMDN: Z110312 CONE BEAM COMPUTED TOMOGRAPHS (CBCT)
- EMDN: Z11039009 FLUOROSCOPY DEVICES
- GMDN: Multi-modality diagnostic x-ray system, mobile (65365)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 1912007532IRm33 · registered 2026-06-10 · status: Active
- **GUDID** · FDA 510(k) · United States · K234067 · decision 2025-03-28 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 19120075320075 · listed 2021-03-22 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K203281 · decision 2020-12-22 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: Loop-X [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Multi-modality diagnostic x-ray system, mobile [FDA GUDID (AccessGUDID)]
- Device name: ImagingRing m [EUDAMED]
- Model / Ref / Catalog: P04-2 [EUDAMED, FDA GUDID (AccessGUDID)]; 1 [FDA GUDID (AccessGUDID)]; 2 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 19120075320075 [EUDAMED, FDA GUDID (AccessGUDID)]; 19120075320129 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 1912007532IRm33 [EUDAMED]
- Direct marketing DI: 19120075320075 [EUDAMED]; 19120075320129 [EUDAMED]
- 510(k) Number: K203281 [FDA GUDID (AccessGUDID)]; K234067 [FDA GUDID (AccessGUDID)]
- FDA product code: OWB [FDA GUDID (AccessGUDID)]
- EMDN code: Z110312 [EUDAMED]; Z11039009 [EUDAMED]
- GMDN term: Multi-modality diagnostic x-ray system, mobile (65365) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.1650 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Austria [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]; 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)]

## Source and citation

- Cite as: Loop-X 1, medPhoton GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/loop-x-p04-2 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/loop-x-p04-2.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/loop-x-p04-2
- 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.