Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K203681 |
Device Name |
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review |
Applicant |
Brainlab AG |
Olof-Palme-Str. 9 |
Munich,
DE
81829
|
|
Applicant Contact |
Chiara Cunico |
Correspondent |
Brainlab AG |
Olof-Palme-Str. 9 |
Munich,
DE
81829
|
|
Correspondent Contact |
Chiara Cunico |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 12/17/2020 |
Decision Date | 04/09/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|