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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K952485
Device Name LASERNET IMAGE MANAGER/PRINT SERVER
Applicant
Frantz Imaging, Inc.
7740 Metric Dr.
Mentor,  OH  44060
Applicant Contact DALE E MCDANIEL
Correspondent
Frantz Imaging, Inc.
7740 Metric Dr.
Mentor,  OH  44060
Correspondent Contact DALE E MCDANIEL
Regulation Number892.2030
Classification Product Code
LMA  
Date Received05/30/1995
Decision Date 11/24/1995
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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