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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K012490
Device Name ORION DIGITAL IMAGING SYSTEM
Applicant
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact RALPH J FLATAU
Correspondent
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact RALPH J FLATAU
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received08/03/2001
Decision Date 02/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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