Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K112096 |
Device Name |
IMAGELINK |
Applicant |
COMPUTER PROGRAMS AND SYSTEMS, INC. |
6600 WALL STREET |
MOBILE,
AL
36695 -4512
|
|
Applicant Contact |
MICHAEL HUNT |
Correspondent |
COMPUTER PROGRAMS AND SYSTEMS, INC. |
6600 WALL STREET |
MOBILE,
AL
36695 -4512
|
|
Correspondent Contact |
MICHAEL HUNT |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/22/2011 |
Decision Date | 09/30/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|