CT6485, CT12885

System, X-ray, Tomography, Computed

Analogic Corporation

The following data is part of a premarket notification filed by Analogic Corporation with the FDA for Ct6485, Ct12885.

Pre-market Notification Details

Device IDK172058
510k NumberK172058
Device Name:CT6485, CT12885
ClassificationSystem, X-ray, Tomography, Computed
Applicant Analogic Corporation 8 Centennial Drive Peabody,  MA  01960
ContactKaren Provencher
CorrespondentKaren Provencher
Analogic Corporation 8 Centennial Drive Peabody,  MA  01960
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-06
Decision Date2018-02-13
Summary:summary

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