Data / Medical devices / Poland / Demant Technology Centre Sp. z o.o.
Demant Technology Centre Sp. z o.o.: FDA-registered device maker in Warsaw Mazowieckie, Poland, 1 510(k) clearance
Demant Technology Centre Sp. z o.o. is registered with the FDA (registration 3014404697) in Warsaw Mazowieckie, Poland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 8, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014404697
- Address
- Q22, Al. Jana Pawla II 22, 9th Floor, Warsaw Mazowieckie, Poland, 00-133
- Owner or operator
- VISION RT LIMITED (9063759)
- Roles
- Specification developer
- First device listed
- January 31, 2013
- Registered through
- 2026
- Brand names listed
- AlignRT, AlignRT Plus, AlignRT SRS module, AlignRT system, GateCT system, GateRT system, OSMS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 8, 2013 | K123371 | ALIGNRT PLUS | IYE | Substantially Equivalent | Vision RT Limited | accessdata.fda.gov |
Compare with other makers
Updated January 8, 2013. 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.