Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K061834 |
Device Name |
XCAT; XCAT FOR NEURO |
Applicant |
XORAN TECHNOLOGIES, INC. |
309 N. FIRST STREET |
ANN ARBOR,
MI
48103 -3301
|
|
Applicant Contact |
JIM BERTOLINA |
Correspondent |
XORAN TECHNOLOGIES, INC. |
309 N. FIRST STREET |
ANN ARBOR,
MI
48103 -3301
|
|
Correspondent Contact |
JIM BERTOLINA |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 06/29/2006 |
Decision Date | 08/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|