GammaTile
Source, Brachytherapy, Radionuclide
Isoray Medical Inc.
The following data is part of a premarket notification filed by Isoray Medical Inc. with the FDA for Gammatile.
Pre-market Notification Details
| Device ID | K180515 |
| 510k Number | K180515 |
| Device Name: | GammaTile |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | Isoray Medical Inc. 350 Hills Street, Suite 106 Richland, WA 99354 |
| Contact | Bill Joy |
| Correspondent | Bill Joy Isoray Medical Inc. 350 Hills Street, Suite 106 Richland, WA 99354 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-27 |
| Decision Date | 2018-07-06 |
| Summary: | summary |
Trademark Results [GammaTile]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMATILE 88226299 not registered Live/Pending |
GT MEDICAL TECHNOLOGIES, INC. 2018-12-12 |
 GAMMATILE 86570994 not registered Dead/Abandoned |
GT MEDICAL TECHNOLOGIES, INC. 2015-03-20 |
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