Device Classification Name |
system, radiation therapy, radionuclide
|
510(k) Number |
K190844 |
Device Name |
Akesis Galaxy |
Applicant |
Akesis Inc |
5129 Commercial Circle |
Concord,
CA
94520
|
|
Applicant Contact |
Christopher Brown |
Correspondent |
Akesis Inc |
5129 Commercial Circle |
Concord,
CA
94520
|
|
Correspondent Contact |
Christopher Brown |
Regulation Number | 892.5750
|
Classification Product Code |
|
Date Received | 04/01/2019 |
Decision Date | 09/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|