| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K963037 |
| Device Name |
PATRIOT |
| Applicant |
| Infimed, Inc. |
| 121 Metropolitan Dr. |
|
Liverpool,
NY
13088
|
|
| Applicant Contact |
MORTEZA MINAEE |
| Correspondent |
| Infimed, Inc. |
| 121 Metropolitan Dr. |
|
Liverpool,
NY
13088
|
|
| Correspondent Contact |
MORTEZA MINAEE |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 08/05/1996 |
| Decision Date | 09/27/1996 |
| 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
|
|
|