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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 K905278
Device Name STS(TM) FLUOROSCOPIC IMAGING MODULE
Applicant
Medstone Intl., Inc.
9975 Toledo
Irvine,  CA  92718
Applicant Contact ENID ROKAW
Correspondent
Medstone Intl., Inc.
9975 Toledo
Irvine,  CA  92718
Correspondent Contact ENID ROKAW
Regulation Number892.1650
Classification Product Code
JAA  
Date Received11/23/1990
Decision Date 02/04/1991
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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