| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K925664 |
| Device Name |
SERIES V-SCAN RADIOGRAPHIC FILM SCANNER |
| Applicant |
| Vision Ten, Inc. |
| 1880 Crenshaw Blvd. |
|
Torrance,
CA
90501
|
|
| Applicant Contact |
PAUL CRONIN |
| Correspondent |
| Vision Ten, Inc. |
| 1880 Crenshaw Blvd. |
|
Torrance,
CA
90501
|
|
| Correspondent Contact |
PAUL CRONIN |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 11/10/1992 |
| Decision Date | 06/22/1993 |
| 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
|
|
|