T-QUEST SYSTEM


Device Classification Name

camera, scintillation (gamma)

510(k) Number K073456
Device Name T-QUEST SYSTEM
Applicant
MEDX, INC.
3456 north ridge ave., #100
arlington heights, 
IL 
60004

Applicant Contact michael hanushewsky
Regulation Number 892.1100
Classification Product Code
IYX  
Date Received 12/10/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No