Cardiology
InVision Precision Cardiac Amyloid
InVision Medical Technology Corporation
The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
FDA Submission Metadata
- Submission number
- K243866
- Decision date
- May 2025
- FDA panel
- Cardiovascular
- Product code
- SDJ
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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