K232392
- 510(k) number
- K232392
- Device name
- CT Lung Ventilation Analysis Software (CT:V)
- Applicant
- 4Dmedical Limited AU
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-11-16
- Date received
- 2023-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232392.pdf
Official FDA record: K232392
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.