# K243866: InVision Precision Cardiac Amyloid

- Pathway: 510(k) (Traditional)
- Applicant: InVision Medical Technology Corporation
- Decided: May 21, 2025 after 155 days
- Product code: SDJ (Adjunctive Cardiac Amyloidosis Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962603 (1997). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240860: EchoGo Amyloidosis (1.0), Ultromics Limited (2024) Summary page 5.

## Indications for use
InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography. When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.

Source page: https://510kreport.com/device/K243866
Methodology: https://510kreport.com/methodology