The following data is part of a premarket notification filed by Akesis Inc with the FDA for Akesis Galaxy Rti.
| Device ID | K203146 |
| 510k Number | K203146 |
| Device Name: | Akesis Galaxy RTi |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | Akesis Inc 5129 Commercial Circle Concord, CA 94520 |
| Contact | Christopher Brown |
| Correspondent | Christopher Brown Akesis Inc 5129 Commercial Circle Concord, CA 94520 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-21 |
| Decision Date | 2021-03-05 |