Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K080540 |
Device Name |
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 |
Applicant |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
NO.3-11, WENHUA ROAD |
HEPING DISTRICT |
SHENYANG, LIAONING,
CN
110004
|
|
Applicant Contact |
TIAN YANFANG |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 02/27/2008 |
Decision Date | 03/13/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|