| Device Classification Name |
System, Simulation, Radiation Therapy
|
| 510(k) Number |
K853671 |
| Device Name |
BEAMSCAN |
| Applicant |
| Victoreen, Inc. |
| 100 Voice Rd. |
|
Carle Place,
NY
11514
|
|
| Applicant Contact |
GLASSER |
| Correspondent |
| Victoreen, Inc. |
| 100 Voice Rd. |
|
Carle Place,
NY
11514
|
|
| Correspondent Contact |
GLASSER |
| Regulation Number | 892.5840 |
| Classification Product Code |
|
| Date Received | 09/04/1985 |
| Decision Date | 01/10/1986 |
| 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
|
|
|