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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, Fluoroscopic, Image-Intensified
510(k) Number K925251
Device Name LIXI IMAGING SCOPE. MODIFICATION
Applicant
Lixi, Inc.
1438 Brook Dr.
Downers Grove,  IL  60515
Applicant Contact ROBERT J SAVINI
Correspondent
Lixi, Inc.
1438 Brook Dr.
Downers Grove,  IL  60515
Correspondent Contact ROBERT J SAVINI
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/16/1992
Decision Date 12/28/1992
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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