Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K140271 |
Device Name |
TABLET VIEWER SOFTWARE FOR IMAGE SUITE |
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 | 02/03/2014 |
Decision Date | 04/01/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|