Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K103394 |
Device Name |
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) |
Applicant |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
911 HANSEN WAY |
PALO ALTO,
CA
94304
|
|
Applicant Contact |
VY TRAN |
Correspondent |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
911 HANSEN WAY |
PALO ALTO,
CA
94304
|
|
Correspondent Contact |
VY TRAN |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 11/19/2010 |
Decision Date | 01/12/2011 |
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
|
|
|