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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K063482
Device Name CROSSPLAN / ACCUSOFT-XL V.4.04
Applicant
Direx Systems Corp.
437 Tpke. St.
Canton,  MA  02021
Applicant Contact LARISA GERSHTEIN
Correspondent
Direx Systems Corp.
437 Tpke. St.
Canton,  MA  02021
Correspondent Contact LARISA GERSHTEIN
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/17/2006
Decision Date 12/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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