Devices · InVision Medical Technology Corporation

InVision Precision Cardiac Amyloid

InVision Medical Technology Corporation is listed for InVision Precision Cardiac Amyloid (K243866). The FDA list gives May 21, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SDJ as “Adjunctive Cardiac Amyloidosis Status Indicator”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243866

Official FDA database record

Date of final decision

May 21, 2025

Company on the FDA list

InVision Medical Technology Corporation

Lead panel

Cardiovascular

Primary product code

SDJ

openFDA device name for the code

Adjunctive Cardiac Amyloidosis Status Indicator

Device class

2

Regulation number

870.2200

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary