IG4 IMAGE GUIDED SYSTEM

System, X-ray, Tomography, Computed

VERAN MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Ig4 Image Guided System.

Pre-market Notification Details

Device IDK060903
510k NumberK060903
Device Name:IG4 IMAGE GUIDED SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant VERAN MEDICAL TECHNOLOGIES, INC. 2409 21ST AVENUE SOUTH SUITE 205 Nashville,  TN  37212
ContactTorsten M Lyon
CorrespondentTorsten M Lyon
VERAN MEDICAL TECHNOLOGIES, INC. 2409 21ST AVENUE SOUTH SUITE 205 Nashville,  TN  37212
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-03
Decision Date2006-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815686020705 K060903 000
00815686020699 K060903 000

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