Optimized Positioning System (OPS) Insight

System, Image Processing, Radiological

Corin USA

The following data is part of a premarket notification filed by Corin Usa with the FDA for Optimized Positioning System (ops) Insight.

Pre-market Notification Details

Device IDK192656
510k NumberK192656
Device Name:Optimized Positioning System (OPS) Insight
ClassificationSystem, Image Processing, Radiological
Applicant Corin USA 12750 Citrus Park Lane, Suite 120 Tampa,  FL  33625
ContactLucinda Gerber
CorrespondentCrissy Tomarelli
Corin (Australia) 17 Bridge Street Sydney,  AU 2073
Product CodeLLZ  
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
Subsequent Product CodeMEH
Subsequent Product CodePLW
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-25
Decision Date2020-05-01

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