Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K232870 |
Device Name |
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) |
Applicant |
Varian Medical Systems, Inc |
3100 Hansen Way |
Palo Alto,
CA
94304
|
|
Applicant Contact |
Lynn Allman |
Correspondent |
Varian Medical Systems, Inc |
3100 Hansen Way |
Palo Alto,
CA
94304
|
|
Correspondent Contact |
Lynn Allman |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 09/15/2023 |
Decision Date | 12/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|