K233875
- 510(k) number
- K233875
- Device name
- Brainomix 360 e-Lung
- Applicant
- Brainomix Limited GB
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-05-13
- Date received
- 2023-12-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233875.pdf
Official FDA record: K233875
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.