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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K193042
Device Name Optimized Positioning System (OPS) ReView
Applicant
Corin USA
12750 Citrus Park Lane
Suite 120
Tampa,  FL  33625
Applicant Contact Lucinda Gerber
Correspondent
Corin (Australia)
17 Bridge St.
Pymble,  AU 2073
Correspondent Contact Martina Cecconi
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
LWJ   LZO   MEH   PLW  
Date Received10/31/2019
Decision Date 06/26/2020
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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