Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K180289 |
Device Name |
3D Bolus Software |
Applicant |
3D Bolus, Inc. |
1344 Summer St |
Suite 3015 |
Halifax,
CA
B3H 0A8
|
|
Applicant Contact |
Peter Hickey |
Correspondent |
3D Bolus, Inc. |
1344 Summer St |
Suite 3015 |
Halifax,
CA
B3H 0A8
|
|
Correspondent Contact |
Peter Hickey |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 02/01/2018 |
Decision Date | 07/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|