| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K952914 |
| Device Name |
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM |
| Applicant |
| Star Technologies, Inc. |
| 515 Shaw Rd. |
|
Sterling,
VA
20166
|
|
| Applicant Contact |
STAN D SURRETTE |
| Correspondent |
| Star Technologies, Inc. |
| 515 Shaw Rd. |
|
Sterling,
VA
20166
|
|
| Correspondent Contact |
STAN D SURRETTE |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 06/26/1995 |
| Decision Date | 09/18/1995 |
| 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
|
|
|