Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K170751 |
Device Name |
MRIdian Linac System with 138-leaf Collimator |
Applicant |
ViewRay Incorporated |
2 Thermo Fisher Way |
Oakwood Village,
OH
44146
|
|
Applicant Contact |
Sean Delaney |
Correspondent |
ViewRay Incorporated |
2 Thermo Fisher Way |
Oakwood Village,
OH
44146
|
|
Correspondent Contact |
Sean Delaney |
Regulation Number | 892.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/13/2017 |
Decision Date | 06/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|