K240553
- 510(k) number
- K240553
- Device name
- LVivo Software Application
- Applicant
- Dia Imaging Analysis, Ltd. IL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-10-04
- Date received
- 2024-02-28
- 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: K240553.pdf
Official FDA record: K240553
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.