ONCO TRAC MODEL 1, 2, 4


Device Classification Name

system, image processing, radiological

510(k) Number K111642
Device Name ONCO TRAC MODEL 1, 2, 4
Applicant
TRANSLATIONAL SCIENCES CORPORATION
one mifflin place
suite 400
cambridge, 
MA 
02138

Applicant Contact allen green, md, phd, jd
Correspondent
TRANSLATIONAL SCIENCES CORPORATION
one mifflin place
suite 400
cambridge, 
MA 
02138

Correspodent Contact allen green, md, phd, jd
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/13/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No