Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K140823 |
Device Name |
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER |
Applicant |
VARIAN MEDICAL SYSTEMS, INC. |
2101 4th Ave Ste 100 |
SEATTLE,
WA
98121
|
|
Applicant Contact |
LISA LEVINE |
Correspondent |
VARIAN MEDICAL SYSTEMS, INC. |
2101 4th Ave Ste 100 |
SEATTLE,
WA
98121
|
|
Correspondent Contact |
LISA LEVINE |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 04/01/2014 |
Decision Date | 06/27/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|