K242270
- 510(k) number
- K242270
- Device name
- OrthoNext Platform System
- Applicant
- Orthofix Srl IT
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-12-19
- Date received
- 2024-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242270.pdf
Official FDA record: K242270
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.