Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K170434 |
Device Name |
Enterprise Imaging XERO Viewer 8.1 |
Applicant |
Agfa HealthCare N.V. |
Septestraat 27 |
Mortsel,
BE
b-2640
|
|
Applicant Contact |
Jodi Coleman |
Correspondent |
Agfa HealthCare Corporation |
10 South Academy Street |
Greenville,
SC
29601
|
|
Correspondent Contact |
ShaeAnn Cavanagh |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/13/2017 |
Decision Date | 07/03/2017 |
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
|
|
|