| Device Classification Name |
Device, Digital Image Storage, Radiological
|
| 510(k) Number |
K952238 |
| Device Name |
VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) |
| Applicant |
| Imaging Concepts, Inc. |
| 8010 Staples Mill Rd. |
|
Richmond,
VA
23228
|
|
| Applicant Contact |
WILLIAM E WILLIAMS |
| Correspondent |
| Imaging Concepts, Inc. |
| 8010 Staples Mill Rd. |
|
Richmond,
VA
23228
|
|
| Correspondent Contact |
WILLIAM E WILLIAMS |
| Regulation Number | 892.2010 |
| Classification Product Code |
|
| Date Received | 05/12/1995 |
| Decision Date | 02/21/1996 |
| 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
|
|
|