IMACTIS CT-Navigation System

System, X-ray, Tomography, Computed

IMACTIS, SAS

The following data is part of a premarket notification filed by Imactis, Sas with the FDA for Imactis Ct-navigation System.

Pre-market Notification Details

Device IDK162314
510k NumberK162314
Device Name:IMACTIS CT-Navigation System
ClassificationSystem, X-ray, Tomography, Computed
Applicant IMACTIS, SAS 5 AVENUE DU GRAND SABLON La Tronche,  FR 38700
ContactMady Batailh
CorrespondentMady Batailh
IMACTIS, SAS 5 AVENUE DU GRAND SABLON La Tronche,  FR 38700
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-18
Decision Date2018-04-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B681J020000 K162314 000
B681J001971 K162314 000
B681J00099US0 K162314 000
B681I101002 K162314 000
B681A102001 K162314 000
B681A100101 K162314 000

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