NEUCOLONCARE


Device Classification Name

system, image processing, radiological

510(k) Number K110077
Device Name NEUCOLONCARE
Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no. 16, shiji road
hunnan indusrtial area
shenyang, liaoning, 

CN

110179

Applicant Contact tian yeuhui
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 01/11/2011
Decision Date 01/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No