K244012
- 510(k) number
- K244012
- Device name
- Mosaic (V1.0.1)
- Applicant
- Navier Medical AU
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-06-16
- Date received
- 2024-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K244012.pdf
Official FDA record: K244012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.