K250367
- 510(k) number
- K250367
- Device name
- CoLumboX
- Applicant
- Smart Soft Healthcare AD BG
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-05-28
- Date received
- 2025-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250367.pdf
Official FDA record: K250367
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.