Device Classification Name |
system, radiation therapy, radionuclide
|
510(k) Number |
K173789 |
Device Name |
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon |
Applicant |
Elekta Instrument AB |
Kungstensgatan 18 |
Stockholm,
SE
10393
|
|
Applicant Contact |
Alf Laurell |
Correspondent |
Elekta Instrument AB |
Kungstensgatan 18 |
Stockholm,
SE
10393
|
|
Correspondent Contact |
Alf Laurell |
Regulation Number | 892.5750
|
Classification Product Code |
|
Date Received | 12/14/2017 |
Decision Date | 03/30/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|