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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K180571
Device Name GammaPod
Applicant
Xcision Medical Systems, LLC
9176 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact Daniel R. Plonski
Correspondent
Xcision Medical Systems, LLC
9176 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact Daniel R. Plonski
Regulation Number892.5750
Classification Product Code
IWB  
Date Received03/05/2018
Decision Date 04/04/2018
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
Recalls CDRH Recalls
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