Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K060903 |
Device Name |
IG4 IMAGE GUIDED SYSTEM |
Applicant |
VERAN MEDICAL TECHNOLOGIES, INC. |
2409 21ST AVENUE SOUTH |
SUITE 205 |
NASHVILLE,
TN
37212
|
|
Applicant Contact |
TORSTEN M LYON |
Correspondent |
VERAN MEDICAL TECHNOLOGIES, INC. |
2409 21ST AVENUE SOUTH |
SUITE 205 |
NASHVILLE,
TN
37212
|
|
Correspondent Contact |
TORSTEN M LYON |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 04/03/2006 |
Decision Date | 05/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|