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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, Stationary
510(k) Number K973710
Device Name DIGITAL ADD ON MULTI SYSTEM
Applicant
Swissray International, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact MORTEZA MINAEE
Correspondent
Swissray International, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact MORTEZA MINAEE
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/29/1997
Decision Date 12/18/1997
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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