Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K063153 |
Device Name |
NOVAPACS |
Applicant |
NOVARAD CORP. |
758 EAST UTAH VALLEY DR. |
SUITE 200 |
AMERICAN FORK,
UT
84003
|
|
Applicant Contact |
PAUL SHUMWAY |
Correspondent |
NOVARAD CORP. |
758 EAST UTAH VALLEY DR. |
SUITE 200 |
AMERICAN FORK,
UT
84003
|
|
Correspondent Contact |
PAUL SHUMWAY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/16/2006 |
Decision Date | 12/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|