K242123
- 510(k) number
- K242123
- Device name
- Brainomix 360 e-CTA
- Applicant
- Brainomix Limited GB
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-01-06
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K242123.pdf
Official FDA record: K242123
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.