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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K820658
Device Name LIXISCOPE - OR LIXI
Applicant
LIXI, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
LIXI, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number892.1650
Classification Product Code
OXO  
Date Received03/10/1982
Decision Date 05/18/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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