Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K221448 |
Device Name |
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) |
Applicant |
Varian Medical Systems, Inc |
3100 Hansen Way |
Palo Alto,
CA
94304
|
|
Applicant Contact |
Peter J. Coronado |
Correspondent |
Varian Medical Systems, Inc |
3100 Hansen Way |
Palo Alto,
CA
94304
|
|
Correspondent Contact |
Peter J. Coronado |
Regulation Number | 892.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/18/2022 |
Decision Date | 06/15/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|