Device Classification Name |
system, radiation therapy, radionuclide
|
510(k) Number |
K151561 |
Device Name |
Leksell Gamma Knife Icon |
Applicant |
ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 |
STOCKHOLM,
SE
10393
|
|
Applicant Contact |
MATILDA FORSBERG |
Correspondent |
ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 |
STOCKHOLM,
SE
10393
|
|
Correspondent Contact |
MATILDA FORSBERG |
Regulation Number | 892.5750
|
Classification Product Code |
|
Date Received | 06/10/2015 |
Decision Date | 08/04/2015 |
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
|
|
|