Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K120551 |
Device Name |
SIMUPLAN TREATMENT PLANNING SYSTEM |
Applicant |
SIMUPLAN S.L. |
1917 29 3/4 AVE |
RICE LAKE,
WI
54868
|
|
Applicant Contact |
LU ANNE JOHNSON |
Correspondent |
SIMUPLAN S.L. |
1917 29 3/4 AVE |
RICE LAKE,
WI
54868
|
|
Correspondent Contact |
LU ANNE JOHNSON |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 02/23/2012 |
Decision Date | 06/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|