NEUVIZ SPIRAL CT SCANNER SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K072841
Device Name NEUVIZ SPIRAL CT SCANNER SYSTEM
Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no.3-11, wenhua road
heping district
shenyang, liaoning, 

CN

110004

Applicant Contact tian tanfang
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 10/04/2007
Decision Date 10/16/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No