Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X— 510(k) K203281

Substantially Equivalent

Medphoton GmbH

FDA 510(k) clearance K203281 for Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X, Substantially Equivalent on 2020-12-22. Applicant: Medphoton GmbH.

Clearance details

Applicant: Medphoton GmbH
Product code: Code OWB
Advisory panel: Radiology
Date received: 2020-11-06
Decision date: 2020-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salzburg, AT

Download summary PDF View on FDA.gov ↗

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.