Device Classification Name |
Source, Brachytherapy, Radionuclide
|
510(k) Number |
K180515 |
Device Name |
GammaTile |
Applicant |
Isoray Medical Inc. |
350 Hills Street, Suite 106 |
Richland,
WA
99354
|
|
Applicant Contact |
Bill Joy |
Correspondent |
Isoray Medical Inc. |
350 Hills Street, Suite 106 |
Richland,
WA
99354
|
|
Correspondent Contact |
Bill Joy |
Regulation Number | 892.5730
|
Classification Product Code |
|
Date Received | 02/27/2018 |
Decision Date | 07/06/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|