MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM

Device Classification Name

system, x-ray, tomography, computed

510(k) Number K071308
Device Name MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no. 16, shiji road
hunnan industrial area
shenyang, liaoning, 

CN

110179

Applicant Contact tian yanfang
Correspondent
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no. 16, shiji road
hunnan industrial area
shenyang, liaoning, 

CN

110179

Correspodent Contact tian yanfang
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 05/09/2007
Decision Date 08/16/2007
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