Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K132824 |
Device Name |
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION |
Applicant |
CARESTREAM HEALTH,INC. |
8708 CAPEHART COVE |
austin,
TX
78733
|
|
Applicant Contact |
david c furr |
Correspondent |
CARESTREAM HEALTH,INC. |
8708 CAPEHART COVE |
austin,
TX
78733
|
|
Correspondent Contact |
david c furr |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/09/2013 |
Decision Date | 02/06/2014 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|