Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K151774 |
Device Name |
CARESTREAM Vue Motion |
Applicant |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Applicant Contact |
CAROLYN L WAGNER |
Correspondent |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Correspondent Contact |
CAROLYN L WAGNER |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/01/2015 |
Decision Date | 09/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|