| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K925050 |
| Device Name |
PC TELERADIOLOGY(TM) |
| Applicant |
| Arizona State Radiology |
| 1845 W. Orange Grove Rd. |
| Bldg. #3 |
|
Tucson,
AZ
85704
|
|
| Applicant Contact |
PHILLIP BERMAN |
| Correspondent |
| Arizona State Radiology |
| 1845 W. Orange Grove Rd. |
| Bldg. #3 |
|
Tucson,
AZ
85704
|
|
| Correspondent Contact |
PHILLIP BERMAN |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 10/06/1992 |
| Decision Date | 05/03/1993 |
| 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
|
|
|