Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K013535 |
Device Name |
EVTOOL MODEL # V. 1.0 |
Applicant |
3D LINE USA, INC. |
2807 OLD COURT RD. |
BALTIMORE,
MD
21208
|
|
Applicant Contact |
KAREN RIGAMONTI |
Correspondent |
3D LINE USA, INC. |
2807 OLD COURT RD. |
BALTIMORE,
MD
21208
|
|
Correspondent Contact |
KAREN RIGAMONTI |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 10/23/2001 |
Decision Date | 01/18/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|