Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K133331 |
Device Name |
4D INTEGRATED TREATMENT CONSOLE |
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 |
|
Date Received | 10/29/2013 |
Decision Date | 01/27/2014 |
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
|
|
|