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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K033955
Device Name RTIST
Applicant
Mirada Solutions , Ltd.
Cti Molecular Imaging, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Applicant Contact MARIA EBIO
Correspondent
Mirada Solutions , Ltd.
Cti Molecular Imaging, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Correspondent Contact MARIA EBIO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/22/2003
Decision Date 03/17/2004
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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