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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 K912250
Device Name ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
Applicant
Theta Systems, Inc.
6425 Anderson Way
Melbourne,  FL  32940
Applicant Contact KEVIN RUSSELL
Correspondent
Theta Systems, Inc.
6425 Anderson Way
Melbourne,  FL  32940
Correspondent Contact KEVIN RUSSELL
Regulation Number892.5750
Classification Product Code
IWB  
Date Received05/21/1991
Decision Date 11/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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