510(k) · Cardiovascular

InVision Precision Cardiac Amyloid

by InVision Medical Technology Corporation

InVision Precision Cardiac Amyloid is an AI-enabled medical device from InVision Medical Technology Corporation that the U.S. FDA cleared through 510(k) K243866 on May 21, 2025. Its lead review panel is Cardiovascular and its primary product code is SDJ (Adjunctive Cardiac Amyloidosis Status Indicator).

See also FDA-cleared AI cardiovascular devices in 2025, all FDA AI clearances in 2025, top cardiovascular AI devices.

Key facts

Submission numberK243866
Pathway510(k)
Date of final decision
Company (FDA list)InVision Medical Technology Corporation
Lead review panelCardiovascular
Primary product codeSDJ — Adjunctive Cardiac Amyloidosis Status Indicator
Applicant (openFDA)InVision Medical Technology Corporation
Applicant locationLos Angeles, CA, US
Device classClass 2
Regulation number21 CFR 870.2200
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. InVision Precision Cardiac Amyloid went through this pathway (K243866).

openFDA lists it as a Class 2 device under 21 CFR 870.2200. Class II devices are moderate risk and are subject to general and special controls.

Product code SDJ covers 3 devices on the FDA AI list. By decision date, this device is #2 of 3 under that code. InVision Medical Technology Corporation has 2 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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