NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0


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
Regulation Number 892.1750
Classification Product Code
JAK  
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