Device Classification Name |
System, X-Ray, Stationary
|
510(k) Number |
K091889 |
Device Name |
DRX-EVOLUTION, MODEL VX3733-SYS |
Applicant |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Applicant Contact |
CAROLYN WAGNER |
Correspondent |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Correspondent Contact |
CAROLYN WAGNER |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 06/24/2009 |
Decision Date | 07/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|