| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K041782 |
| Device Name |
SEEMOR 5.0 IMAGE DISPLAY PROGRAM |
| Applicant |
| Areeda Assoc., Ltd. |
| 516 N. Curson Ave. |
|
Los Angeles,
CA
90036
|
|
| Applicant Contact |
JOSEPH AREEDA |
| Correspondent |
| Areeda Assoc., Ltd. |
| 516 N. Curson Ave. |
|
Los Angeles,
CA
90036
|
|
| Correspondent Contact |
JOSEPH AREEDA |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 07/01/2004 |
| Decision Date | 08/16/2004 |
| 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
|
|
|