K243862
- 510(k) number
- K243862
- Device name
- LVivo Software Application
- Applicant
- Dia Imaging Analysis, Ltd. IL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-03-17
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243862.pdf
Official FDA record: K243862
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.