Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K211881 |
Device Name |
AI Segmentation |
Applicant |
Varian Medical Systems, Inc. |
3100 Hansen Way |
Palo Alto,
CA
94304
|
|
Applicant Contact |
Peter Coronado |
Correspondent |
Varian Medical Systems, Inc. |
3100 Hansen Way |
Palo Alto,
CA
94304
|
|
Correspondent Contact |
Peter Coronado |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/21/2021 |
Decision Date | 09/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|