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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K040553
Device Name MODIFICATION TO ACCULEAF
Applicant
Direx Systems Corp.
11 Mercer Rd.
Business Park
Natick,  MA  01760
Applicant Contact LARISA GERSHTEIN
Correspondent
Direx Systems Corp.
11 Mercer Rd.
Business Park
Natick,  MA  01760
Correspondent Contact LARISA GERSHTEIN
Regulation Number892.5710
Classification Product Code
IXI  
Date Received03/02/2004
Decision Date 04/01/2004
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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