| Device Classification Name |
system, image processing, radiological
|
|---|
| 510(k) Number |
K011694 |
|---|
| Device Name |
VIEWSTATION |
|---|
| Applicant |
| IMPAC MEDICAL SYSTEMS, INC. |
| 100 WEST EVELYN AVE. |
|
MOUNTAIN VIEW,
CA
94041 -1464
|
|
| Applicant Contact |
THOMAS H FARIS |
| Correspondent |
| IMPAC MEDICAL SYSTEMS, INC. |
| 100 WEST EVELYN AVE. |
|
MOUNTAIN VIEW,
CA
94041 -1464
|
|
| Correspondent Contact |
THOMAS H FARIS |
| Regulation Number | 892.2050
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/31/2001 |
|---|
| Decision Date | 08/29/2001 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|