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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 K953163
Device Name QUICK READ 2000 (QR2000)
Applicant
Quicksilver Systems, Inc.
6504 Sweetwater Dr.
Rockville,  MD  20855
Applicant Contact WALT GUNDAKER
Correspondent
Quicksilver Systems, Inc.
6504 Sweetwater Dr.
Rockville,  MD  20855
Correspondent Contact WALT GUNDAKER
Regulation Number892.2020
Classification Product Code
LMD  
Date Received07/07/1995
Decision Date 09/22/1995
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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