| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K040686 |
| Device Name |
M'ATH STD |
| Applicant |
| Intelligence IN Medical Technologies |
| P.O. Box 222 |
|
Hartland,
WI
53029
|
|
| Applicant Contact |
SCOTT PEASE |
| Correspondent |
| Intelligence IN Medical Technologies |
| P.O. Box 222 |
|
Hartland,
WI
53029
|
|
| Correspondent Contact |
SCOTT PEASE |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 03/16/2004 |
| Decision Date | 07/30/2004 |
| 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
|
|
|