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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 K150037
Device Name Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
Applicant
Sensus Healthcare
851 Broken Sound Pkwy. NW #215
Boca Raton,  FL  33487
Applicant Contact KAL FISHERMAN
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 Received01/09/2015
Decision Date 10/16/2015
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
Recalls CDRH Recalls
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