Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K920879 |
Device Name |
BRAINSCAN RADIOSURGERY MODULE |
Applicant |
BRAINLAB |
WITTELSBACHERSTR. 8 |
D-8011 POING B. MUNCHEN |
WEST GERMANY,
DE
|
|
Applicant Contact |
STEFAN VILSMEIER |
Correspondent |
BRAINLAB |
WITTELSBACHERSTR. 8 |
D-8011 POING B. MUNCHEN |
WEST GERMANY,
DE
|
|
Correspondent Contact |
STEFAN VILSMEIER |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 02/26/1992 |
Decision Date | 12/29/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|