K234067
- 510(k) number
- K234067
- Device name
- ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
- Applicant
- Medphoton GmbH AT
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-03-28
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K234067.pdf
Official FDA record: K234067
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.