K232331
- 510(k) number
- K232331
- Device name
- InVision Precision LVEF (LVEF)
- Applicant
- InVision Medical Technology Corporation CA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-04-25
- Date received
- 2023-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232331.pdf
Official FDA record: K232331
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.