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Hearttrace Left Ventricular Analysis Software

by Heartware Intl. Corp.

510(k) K933073

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933073 Date7 Oct 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Hearttrace Left Ventricular Analysis Software is a Class II device designed for left ventricular analysis. It is a software system used in radiology for analyzing left ventricular function.

The device is supplied by Heartware Intl. Corp. and is regulated under FDA 510(k) clearance K933073 with product code IZI. It is classified as a System, X-ray, Angiographic device and was cleared on October 7, 1993.

Other devices from Heartware Intl. Corp.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Hearttrace Left Ventricular Analysis Software used for?

    The Hearttrace Left Ventricular Analysis Software is a Class II device designed for analyzing left ventricular function in radiology settings. It helps clinicians assess and evaluate the performance of the left ventricle through specialized software analysis.

  • How is the Hearttrace Left Ventricular Analysis Software supplied?

    The software is supplied by Heartware Intl. Corp. It is a software system that is used in conjunction with imaging equipment to perform left ventricular analysis in radiology departments.

  • What is the regulatory status of the Hearttrace Left Ventricular Analysis Software?

    The device is regulated under FDA 510(k) clearance K933073 with product code IZI. It is classified as a System, X-ray, Angiographic device and was cleared on October 7, 1993, making it substantially equivalent to other devices in this category.

  • Is the Hearttrace Left Ventricular Analysis Software reusable or single-use?

    The Hearttrace Left Ventricular Analysis Software is a software system, which means it can be used multiple times as long as it is properly installed and maintained on compatible hardware. Software does not have the same physical limitations as single-use medical devices.