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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K900062
Device Name U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
Applicant
U.S. Imaging, Inc.
4816 Massillon Rd.
Greensburg,  OH  44232
Applicant Contact MARTIN KULIS
Correspondent
U.S. Imaging, Inc.
4816 Massillon Rd.
Greensburg,  OH  44232
Correspondent Contact MARTIN KULIS
Regulation Number892.1700
Classification Product Code
IZO  
Date Received01/03/1990
Decision Date 02/05/1990
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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