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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K903622
Device Name CT GUIDE (TM)
Applicant
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Applicant Contact DUSAN KOLAR
Correspondent
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Correspondent Contact DUSAN KOLAR
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/09/1990
Decision Date 10/29/1990
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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