Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K093146 |
Device Name |
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 |
Applicant |
VERAN MEDICAL TECHNOLOGIES, INC. |
5743 WEST PARK AVE |
ST. LOUIS,
MO
63110
|
|
Applicant Contact |
SCOTT WRIGHTSTONE |
Correspondent |
VERAN MEDICAL TECHNOLOGIES, INC. |
5743 WEST PARK AVE |
ST. LOUIS,
MO
63110
|
|
Correspondent Contact |
SCOTT WRIGHTSTONE |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 10/05/2009 |
Decision Date | 11/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|