Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K121792 |
Device Name |
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM |
Applicant |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Applicant Contact |
CHARLES MACK |
Correspondent |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Correspondent Contact |
CHARLES MACK |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 06/28/2012 |
Decision Date | 11/16/2012 |
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
|
|
|