Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K041403 |
Device Name |
ECLIPSE WITH AAA |
Applicant |
VARIAN MEDICAL SYSTEMS |
3100 HANSEN WAY |
M/S H055 |
PALO ALTO,
CA
94304 -1129
|
|
Applicant Contact |
VY TRAN |
Correspondent |
VARIAN MEDICAL SYSTEMS |
3100 HANSEN WAY |
M/S H055 |
PALO ALTO,
CA
94304 -1129
|
|
Correspondent Contact |
VY TRAN |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 05/26/2004 |
Decision Date | 07/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|