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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K952533
Device Name SIENET DICOM GATEWAY
Applicant
Siemens AG
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
Siemens AG
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number892.2020
Classification Product Code
LMD  
Date Received06/01/1995
Decision Date 08/23/1995
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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