K193293 is an FDA 510(k) clearance for the XV Lung Ventilation Analysis Software. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.
Submitted by 4Dx Limited (Melbourne, AU). The FDA issued a Cleared decision on May 14, 2020 after a review of 169 days - an extended review cycle.
This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.
View all 4Dx Limited devices
NCT02735746
Completed
Observational
Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis
Novel High Fidelity Functional Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis
| Condition studied |
Lung Cancer; Breast Cancer; Mediastinum Lesion; Radiation Pneumonitis |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Stephen Shiao, MD, PhD |
| Sponsor |
Cedars-Sinai Medical Center
|
Started 2016-08-21
→
Primary completion 2025-06-06
Primary outcome
A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
Secondary outcome
Forced expiratory volume 1 (FEV1)
Study completed - no results published.
This trial concluded in 2025 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov