Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K151403 |
Device Name |
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System |
Applicant |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
NO. 16, SHIJI ROAD |
HUNNAN INDUSTRIAL AREA |
SHENYANG,
CN
110179
|
|
Applicant Contact |
TIAN YUEHUI |
Correspondent |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
NO. 16, SHIJI ROAD |
HUNNAN INDUSTRIAL AREA |
SHENYANG,
CN
110179
|
|
Correspondent Contact |
TIAN YUEHUI |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/26/2015 |
Decision Date | 11/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|