K243866
- 510(k) number
- K243866
- Device name
- InVision Precision Cardiac Amyloid
- Applicant
- InVision Medical Technology Corporation CA · US
- Product code
- SDJ — Adjunctive Cardiac Amyloidosis Status Indicator
- Decision date
- 2025-05-21
- Date received
- 2024-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243866.pdf
Official FDA record: K243866
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.