| Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
| 510(k) Number |
K982821 |
| Device Name |
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7 |
| Applicant |
| Multimedia Medical Systems, Inc. |
| 400 Ray C. Hunt Dr., Suite 380 |
|
Charlottesville,
VA
22903
|
|
| Applicant Contact |
ALEXANDER CROSBY |
| Correspondent |
| Multimedia Medical Systems, Inc. |
| 400 Ray C. Hunt Dr., Suite 380 |
|
Charlottesville,
VA
22903
|
|
| Correspondent Contact |
ALEXANDER CROSBY |
| Regulation Number | 892.5050 |
| Classification Product Code |
|
| Date Received | 08/11/1998 |
| Decision Date | 11/05/1998 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|