Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K013112 |
Device Name |
FOCAL SIM |
Applicant |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
1145 CORPORATE LAKE DR. |
ST. LOUIS,
MO
63132 -1716
|
|
Applicant Contact |
MICHAEL A PARSONS |
Correspondent |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
1145 CORPORATE LAKE DR. |
ST. LOUIS,
MO
63132 -1716
|
|
Correspondent Contact |
MICHAEL A PARSONS |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 09/18/2001 |
Decision Date | 12/05/2001 |
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
|
|
|