Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K170570 |
Device Name |
Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung |
Applicant |
Varian Medical Systems Inc |
3100 Hansen Way |
Palo Alto,
CA
94304 -1038
|
|
Applicant Contact |
Lisa Levine |
Correspondent |
Varian Medical Systems Inc |
3100 Hansen Way |
Palo Alto,
CA
94304 -1038
|
|
Correspondent Contact |
Lisa Levine |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 02/27/2017 |
Decision Date | 04/06/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01396551
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|