Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K161061 |
Device Name |
IMPAX Volume Viewing 4.0 |
Applicant |
AGFA HEALTHCARE N.V. |
SEPTESTRAAT 27 |
MORTSEL,
BE
B-2640
|
|
Applicant Contact |
Koen Cobbaert |
Correspondent |
AGFA HEALTHCARE CORPORATION |
10 SOUTH ACADEMY STREET |
GREENVILLE,
SC
29601
|
|
Correspondent Contact |
ShaeAnn Cavanagh |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/15/2016 |
Decision Date | 06/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|