| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K925465 |
| Device Name |
TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT |
| Applicant |
| Life Care Imaging |
| 235 W. Main St. |
|
Cary,
IL
60013
|
|
| Applicant Contact |
ALAN I BECKER |
| Correspondent |
| Life Care Imaging |
| 235 W. Main St. |
|
Cary,
IL
60013
|
|
| Correspondent Contact |
ALAN I BECKER |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 10/29/1992 |
| Decision Date | 01/27/1993 |
| 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
|
|
|