TRACKPORT


Device Classification Name

accelerator, linear, medical

510(k) Number K072529
Device Name TRACKPORT
Applicant
DIREX SYSTEMS CORP.
437 turnpike st.
canton, 
MA 
02021

Applicant Contact larisa gershtein
Correspondent
DIREX SYSTEMS CORP.
437 turnpike st.
canton, 
MA 
02021

Correspodent Contact larisa gershtein
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 09/07/2007
Decision Date 10/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No