Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K081976 |
Device Name |
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION |
Applicant |
AGFA HEALTHCARE CORPORATION |
10 SOUTH ACADEMY STREET |
GREENVILLE,
SC
29601
|
|
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/11/2008 |
Decision Date | 07/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|