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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 K984000
Device Name STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
Applicant
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Applicant Contact ROGER N WHITE
Correspondent
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Correspondent Contact ROGER N WHITE
Regulation Number892.2020
Classification Product Code
LMD  
Date Received11/10/1998
Decision Date 01/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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