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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High Voltage, X-Ray, Therapeutic
510(k) Number K912249
Device Name PATIENT DOSE MONITOR
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 Number892.5900
Classification Product Code
KPZ  
Date Received05/21/1991
Decision Date 08/30/1991
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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