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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 K970174
Device Name FREEPIX/PIXPACS DICOM/HTTP GATEWAY
Applicant
Pixelinks, Inc.
15 Mark Twain Dr.
Morristown,  NJ  07960
Applicant Contact STEVE BEER
Correspondent
Pixelinks, Inc.
15 Mark Twain Dr.
Morristown,  NJ  07960
Correspondent Contact STEVE BEER
Regulation Number892.2020
Classification Product Code
LMD  
Date Received01/10/1997
Decision Date 05/01/1997
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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