XV Lung Ventilation Analysis Software

System, X-ray, Tomography, Computed

4Dx Limited

The following data is part of a premarket notification filed by 4dx Limited with the FDA for Xv Lung Ventilation Analysis Software.

Pre-market Notification Details

Device IDK193293
510k NumberK193293
Device Name:XV Lung Ventilation Analysis Software
ClassificationSystem, X-ray, Tomography, Computed
Applicant 4Dx Limited Level 5 Suite 3, 468 St Kilda Rd Melbourne,  AU 3004
ContactTerrence Thiel
CorrespondentTerrence Thiel
4DX Limited Level 5 Suite 3, 468 St Kilda Rd Melbourne,  AU 3004
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-27
Decision Date2020-05-14

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.