K242411
- 510(k) number
- K242411
- Device name
- Brainomix 360 e-Lung
- Applicant
- Brainomix Limited GB
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-02-19
- Date received
- 2024-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K242411.pdf
Official FDA record: K242411
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.