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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 K202805
Device Name Optimized Positioning System (OPS) Insight
Applicant
Corin USA
12750 Citrus Park Ln.
Suite 120
Tampa,  FL  33625
Applicant Contact Lucinda Gerber
Correspondent
Corin (Australia)
17 Bridge St.
Pymble,  AU 2073
Correspondent Contact Crissy Tomarelli
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/23/2020
Decision Date 11/20/2020
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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