K190844 is an FDA 510(k) clearance for the Akesis Galaxy. This device is classified as a System, Radiation Therapy, Radionuclide (Class II - Special Controls, product code IWB).
Submitted by Akesis, Inc. (Concord, US). The FDA issued a Cleared decision on September 4, 2019, 156 days after receiving the submission on April 1, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5750.
| 510(k) Number | K190844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2019 |
| Decision Date | September 04, 2019 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWB - System, Radiation Therapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5750 |