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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 K142431
Device Name WaterProof PROFILER
Applicant
Sun Nuclear Corporation
3275 Suntree Blvd.
Melbourne,  FL  32940
Applicant Contact NOEL DOWNEY
Correspondent
Sun Nuclear Corporation
3275 Suntree Blvd.
Melbourne,  FL  32940
Correspondent Contact NOEL DOWNEY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/29/2014
Decision Date 12/05/2014
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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