510(k) K250151

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

June 20, 2025

Date Received

January 21, 2025

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.