Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K181185 |
Device Name |
Change Healthcare Enterprise Viewer |
Applicant |
Change Healthcare Canada Company |
10711 Cambie Road |
Richmond,
CA
V6X3G5
|
|
Applicant Contact |
Nadia Marchant |
Correspondent |
Change Healthcare Technologies LLC. |
10711 Cambie Road |
Richmond,
CA
V6X3G5
|
|
Correspondent Contact |
Nadia Marchant |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/03/2018 |
Decision Date | 08/29/2018 |
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
|
|
|