| Device Classification Name |
System, Simulation, Radiation Therapy
|
| 510(k) Number |
K896555 |
| Device Name |
CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT |
| Applicant |
| W. L. Systems, Inc. |
| P.O. Box 23120 |
| 3302 Goliad Rd. |
|
San Antonio,
TX
78223
|
|
| Applicant Contact |
G WAGGENER |
| Correspondent |
| W. L. Systems, Inc. |
| P.O. Box 23120 |
| 3302 Goliad Rd. |
|
San Antonio,
TX
78223
|
|
| Correspondent Contact |
G WAGGENER |
| Regulation Number | 892.5840 |
| Classification Product Code |
|
| Date Received | 11/17/1989 |
| Decision Date | 04/26/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|