Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K142108 |
Device Name |
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS |
Applicant |
BRAINLAB AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Applicant Contact |
ALEXANDER SCHWIERSCH |
Correspondent |
BRAINLAB AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Correspondent Contact |
ALEXANDER SCHWIERSCH |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 08/04/2014 |
Decision Date | 12/16/2014 |
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
|
|
|