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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 K893521
Device Name IMLOGIX 1000 IMAGE DISPLAY SYSTEM
Applicant
Imlogix A Div. of Microterm
3630 S. Geyer, Suite 300
St. Louis,  MO  63127
Applicant Contact MICHAEL LATAUSKA
Correspondent
Imlogix A Div. of Microterm
3630 S. Geyer, Suite 300
St. Louis,  MO  63127
Correspondent Contact MICHAEL LATAUSKA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/08/1989
Decision Date 06/23/1989
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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