Data / Medical devices / Austria / Medphoton GMBH
Medphoton GMBH: FDA-registered device maker in Salzburg, Austria, 4 510(k) clearances
Medphoton GMBH is registered with the FDA (registration 3012631246) in Salzburg, Austria. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012631246
- Address
- Karolingerstrasse 16, Salzburg, Austria, 5020
- Owner or operator
- medPhoton GmbH (10054933)
- Roles
- Manufacturer
- First device listed
- May 15, 2017
- Registered through
- 2026
- Brand names listed
- IRm, ImagingRing System, ImagingRing System on Rails, ImagingRing m, Loop-X, Loop-X Mobile Imaging Robot, Mobile ImagingRing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2025 | K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | OWB | Substantially Equivalent | Medphoton GmbH | accessdata.fda.gov |
| December 22, 2020 | K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X | OWB | Substantially Equivalent | Medphoton GmbH | accessdata.fda.gov |
| August 1, 2019 | K191267 | ImagingRing System on Rails | IYE | Substantially Equivalent | Medphoton GmbH | accessdata.fda.gov |
| December 8, 2016 | K161400 | ImagingRing System | IYE | Substantially Equivalent | Medphoton GmbH | accessdata.fda.gov |
Compare with other makers
Updated March 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.