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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Nonfetal
510(k) Number K942441
Device Name IMEXDOP CT+
Applicant
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact DENNIS NEWMAN
Correspondent
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact DENNIS NEWMAN
Regulation Number892.1540
Classification Product Code
JAF  
Date Received05/23/1994
Decision Date 08/23/1994
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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