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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 K905199
Device Name PACSNET RESEARCH TOOLKIT
Applicant
SIEMENS GAMMASONICS, INC.
2501 N. BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact DENNIS W HENKELMAN
Correspondent
SIEMENS GAMMASONICS, INC.
2501 N. BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact DENNIS W HENKELMAN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received11/20/1990
Decision Date 01/14/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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