Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K993766 |
Device Name |
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM |
Applicant |
HELAX AB |
447 MARCH ROAD |
KANATA ONTARIO,
CA
K2K 1X8
|
|
Applicant Contact |
E.S. MARTELL |
Correspondent |
HELAX AB |
447 MARCH ROAD |
KANATA ONTARIO,
CA
K2K 1X8
|
|
Correspondent Contact |
E.S. MARTELL |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 11/08/1999 |
Decision Date | 12/08/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|