Device Classification Name |
Irradiator, Blood To Prevent Graft Versus Host Disease
|
510(k) Number |
K181737 |
Device Name |
Raycell MK1 |
Applicant |
Best Theratronics Limited |
413 March Road |
Ottawa,
CA
k2k 0e4
|
|
Applicant Contact |
Mojgan Soleimani |
Correspondent |
Best Theratronics Limited |
413 March Road |
Ottawa,
CA
k2k 0e4
|
|
Correspondent Contact |
Mojgan Soleimani |
Classification Product Code |
|
Date Received | 07/02/2018 |
Decision Date | 01/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|