Corin Optimized Positioning System (OPS™) Plan

System, Image Processing, Radiological

Corin USA Limited

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

Pre-market Notification Details

Device IDK171847
510k NumberK171847
Device Name:Corin Optimized Positioning System (OPS™) Plan
ClassificationSystem, Image Processing, Radiological
Applicant Corin USA Limited 12750 Citrus Park Lane, Suite 120 Tampa,  FL  33625
ContactKathy Trier
CorrespondentMartina Cecconi
Corin USA Limited 12750 Citrus Park Lane, Suite 120 Tampa,  FL  33625
Product CodeLLZ  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-21
Decision Date2018-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09351327000077 K171847 000

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