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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K034051
Device Name DYNATRAC, COD. 50-1A
Applicant
3D Line USA, Inc.
12100 Sunset Hills Rd.
Suite 150
Reston,  VA  20190
Applicant Contact NADER SALEHI
Correspondent
3D Line USA, Inc.
12100 Sunset Hills Rd.
Suite 150
Reston,  VA  20190
Correspondent Contact NADER SALEHI
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/30/2003
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
Predetermined Change
Control Plan Authorized		 No
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