Akesis Galaxy
System, Radiation Therapy, Radionuclide
Akesis Inc
The following data is part of a premarket notification filed by Akesis Inc with the FDA for Akesis Galaxy.
Pre-market Notification Details
| Device ID | K190844 |
| 510k Number | K190844 |
| Device Name: | Akesis Galaxy |
| 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 | 2019-04-01 |
| Decision Date | 2019-09-04 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974783050023 | K190844 | 000 |
Trademark Results [Akesis Galaxy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AKESIS GALAXY 88235895 not registered Live/Pending |
Akesis, Inc. 2018-12-19 |
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