Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K132853 |
Device Name |
NOVAPACS |
Applicant |
NOVARAD CORP. |
752 E 1180 S Ste 200 |
American Fork,
UT
84003
|
|
Applicant Contact |
AMY HOFFMAN |
Correspondent |
NOVARAD CORP. |
752 E 1180 S Ste 200 |
American Fork,
UT
84003
|
|
Correspondent Contact |
Doug Merrill |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/12/2013 |
Decision Date | 10/30/2014 |
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
|
|
|