K241819
- 510(k) number
- K241819
- Device name
- CephNinja
- Applicant
- Cyncronus, LLC WA · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-01-23
- Date received
- 2024-06-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241819.pdf
Official FDA record: K241819
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.