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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K191705
Device Name OptikView GUP2103CMI
Applicant
The Linden Group Corp
2b Wing Dr.
Cedar Knolls,  NJ  07927
Applicant Contact James Chen
Correspondent
Qubyx Software Technologies, Inc.
501 Silverside Rd., Suite 105
Wilmington,  DE  19809
Correspondent Contact Marc Leppla
Regulation Number892.2050
Classification Product Code
PGY  
Date Received06/26/2019
Decision Date 03/16/2020
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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