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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, X-Ray System
510(k) Number K061361
Device Name FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
Applicant
Faxitron X-Ray Corp.
225 Larkin Dr.,Suite 1
Wheeling,  IL  60090
Applicant Contact DOUGLAS C WIEGMAN
Correspondent
Faxitron X-Ray Corp.
225 Larkin Dr.,Suite 1
Wheeling,  IL  60090
Correspondent Contact DOUGLAS C WIEGMAN
Regulation Number892.1680
Classification Product Code
MWP  
Date Received05/16/2006
Decision Date 08/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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