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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K131582
Device Name SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
Applicant
Sensus Healthcare
851 Broken Sound Pkwy. NW #215
Boca Raton,  FL  33487
Applicant Contact KAL FISHMAN
Correspondent
Sensus Healthcare
851 Broken Sound Pkwy. NW #215
Boca Raton,  FL  33487
Correspondent Contact KAL FISHMAN
Regulation Number892.5900
Classification Product Code
JAD  
Date Received05/31/2013
Decision Date 08/28/2013
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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