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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 K915339
Device Name GEN-X 800/300
Applicant
Swissray Finatech, Inc.
7780 Mallard Dr.
Mobile,  AL  36695
Applicant Contact MICHAEL SCOTT
Correspondent
Swissray Finatech, Inc.
7780 Mallard Dr.
Mobile,  AL  36695
Correspondent Contact MICHAEL SCOTT
Regulation Number892.1700
Classification Product Code
IZO  
Date Received11/20/1991
Decision Date 01/09/1992
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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