Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K122523 |
Device Name |
CARESTREAM VUE PACS |
Applicant |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Applicant Contact |
Alexandra Chamberlain |
Correspondent |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Correspondent Contact |
Alexandra Chamberlain |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/20/2012 |
Decision Date | 10/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|