XV Lung Ventilation Analysis Software— 510(k) K193293

Name: FDA 510(k) clearance K193293
Creator: U.S. Food and Drug Administration
Published: 2020-05-14

Substantially Equivalent

4Dx Limited

FDA 510(k) clearance K193293 for XV Lung Ventilation Analysis Software, Substantially Equivalent on 2020-05-14. Applicant: 4Dx Limited. Device class: 2.

Clearance details

Applicant: 4Dx Limited
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2019-11-27
Decision date: 2020-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.