K243235
- 510(k) number
- K243235
- Device name
- LVivo Software Application
- Applicant
- Dia Imaging Analysis, Ltd. IL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-03-03
- Date received
- 2024-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243235.pdf
Official FDA record: K243235
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.