DYNATRAC, COD. 50-1A


Device Classification Name

accelerator, linear, medical

510(k) Number K034051
Device Name DYNATRAC, COD. 50-1A
Applicant
3D LINE USA, INC.
12100 sunset hills road
suite 150
reston, 
VA 
20190

Applicant Contact nader salehi
Correspondent
3D LINE USA, INC.
12100 sunset hills road
suite 150
reston, 
VA 
20190

Correspodent Contact nader salehi
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 12/30/2003
Decision Date 04/05/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No