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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 K142617
Device Name ArcCHECK
Applicant
Sun Nuclear Corporation
3275 Suntree Blvd.
Melbourne,  FL  32940
Applicant Contact Noel Downey
Correspondent
James Luker
2640 Nobility Ave.
Melbourne,  FL  32934
Correspondent Contact James Luker
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/16/2014
Decision Date 11/20/2015
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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