CURA 16; ScintCare CT16

System, X-ray, Tomography, Computed

FMI Medical Systems Inc.

The following data is part of a premarket notification filed by Fmi Medical Systems Inc. with the FDA for Cura 16; Scintcare Ct16.

Pre-market Notification Details

Device IDK173076
510k NumberK173076
Device Name:CURA 16; ScintCare CT16
ClassificationSystem, X-ray, Tomography, Computed
Applicant FMI Medical Systems Inc. 29001 Solon Road, UnitA Solon,  OH  44139
ContactScott Lemaster
CorrespondentPaul Mcfeely
FDA 510k Consultants, LLC 29001 Solon Road Unit A Solon,  OH  44139
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-10-04
Summary:summary

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