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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 K021463
Device Name MODEL 1133 IVD PC VERSION
Applicant
Sun Nuclear Corp.
425-A Pineda Ct.
Melbourne,  FL  32940
Applicant Contact JIM MIXON
Correspondent
Sun Nuclear Corp.
425-A Pineda Ct.
Melbourne,  FL  32940
Correspondent Contact JIM MIXON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/07/2002
Decision Date 06/06/2002
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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