Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K032762 |
Device Name |
XIO RADIATION TREATMENT PLANNING SYSTEM |
Applicant |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
1145 CORPORATE LAKE DR. |
ST. LOUIS,
MO
63132 -1716
|
|
Applicant Contact |
KATHRYN STINSON |
Correspondent |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
1145 CORPORATE LAKE DR. |
ST. LOUIS,
MO
63132 -1716
|
|
Correspondent Contact |
KATHRYN STINSON |
Regulation Number | 892.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/05/2003 |
Decision Date | 12/02/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|