ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)— 510(k) K234067

Name: FDA 510(k) clearance K234067
Creator: U.S. Food and Drug Administration
Published: 2025-03-28

Substantially Equivalent

Medphoton GmbH

FDA 510(k) clearance K234067 for ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0), Substantially Equivalent on 2025-03-28. Applicant: Medphoton GmbH. Device class: 2.

Clearance details

Applicant: Medphoton GmbH
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2023-12-22
Decision date: 2025-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salzburg, AT

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWB

view all

K253726 — uAngio AVIVA CX2026-08-21
K261413 — EXTRON 3; EXTRON 62026-08-19
K254205 — Zenition 302026-08-07
K260607 — Shield System (Siemens 30x40)2026-07-31
K253670 — SmartCT (R3.0 (L10))2026-07-10

More clearances from Medphoton GmbH

view all

K203281 — Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X2020-12-22
K191267 — ImagingRing System on Rails2019-08-01
K161400 — ImagingRing System2016-12-08

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.