Data / Medical devices / United States / GT Medical Technologies, Inc
GT Medical Technologies, Inc: FDA-registered device maker in Tempe, AZ, United States, 4 510(k) clearances
GT Medical Technologies, Inc is registered with the FDA (registration 3014663932) in Tempe, AZ, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 9, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014663932
- Address
- 1809 S Holbrook Ln STE 107, Tempe, AZ, United States, 85281
- Owner or operator
- GT Medical Technologies, Inc (10058091)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 7, 2018
- Registered through
- 2026
- Brand names listed
- GammaTile, GammaTile Radiation Shielding Tray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Shield, Protective, Personnel | KPY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Source, Brachytherapy, Radionuclide | KXK | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 9, 2022 | K221539 | GammaTile | KXK | Substantially Equivalent | Gt Medical Technologies | accessdata.fda.gov |
| January 23, 2020 | K190839 | GammaTile | KXK | Substantially Equivalent | Gt Medical Technologies | accessdata.fda.gov |
| March 13, 2019 | K190296 | GammaTile | KXK | Substantially Equivalent | Gt Medical Technologies | accessdata.fda.gov |
| July 6, 2018 | K180515 | GammaTile | KXK | Substantially Equivalent | Isoray Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2022. 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.