Data / Medical devices / Germany / iRT Systems GmbH
iRT Systems GmbH: FDA-registered device maker in Koblenz Rhineland-Palatinate, Germany, 1 510(k) clearance
iRT Systems GmbH is registered with the FDA (registration 3010875109) in Koblenz Rhineland-Palatinate, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 20, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010875109
- Address
- Schlossstrasse 1, Koblenz Rhineland-Palatinate, Germany, 56068
- Owner or operator
- iRT Systems GmbH (10053403)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 2, 2016
- Registered through
- 2026
- Brand names listed
- IQM, IQM Integral Quality Monitor, IQM System, Integral Quality Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 20, 2016 | K162629 | IQM Integral Quality Monitor (also IQM) | IYE | Substantially Equivalent | Irt Systems | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2016. 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.