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510(k) K243866

InVision Precision Cardiac Amyloid by InVision Medical Technology Corporation — Product Code SDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2025
Date Received
December 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adjunctive Cardiac Amyloidosis Status Indicator
Device Class
Class II
Regulation Number
870.2200
Review Panel
CV
Submission Type

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.

Other clearances by InVision Medical Technology Corporation

  • K232331 — InVision Precision LVEF (LVEF) (April 25, 2024)

Other clearances for product code SDJ

  • K250151 — Us2.ca (June 20, 2025)
  • K240860 — EchoGo Amyloidosis (1.0) (November 15, 2024)