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Medvoxel Heartpro Software Application

by Medvoxel Systems, Inc.

510(k) K103565

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 NumberK103565 Date12 Apr 2011ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Medvoxel Heartpro Software Application is a web-accessible, self-contained software application for cardiovascular image analysis. It uses cardiac-specific MR scans as a data source for blood flow analysis computations and imports pre-existing DICOM-compliant multi-phase and velocity-encoded MR images from PACS or scanners.

The Medvoxel Heartpro Software Application is supplied as a software application and is used in radiology. It has been cleared under FDA 510(k) with the k-number K103565. The application is a Class II device and has been assigned the product code LLZ.

Questions

AI-generated answers, 24 Sep 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 Medvoxel Heartpro Software Application used for?

    The Medvoxel Heartpro Software Application is used for cardiovascular image analysis, specifically for blood flow analysis computations using cardiac-specific MR scans.

  • How is the Medvoxel Heartpro Software Application supplied?

    The Medvoxel Heartpro Software Application is supplied as a software application, accessible via the web.

  • What type of images can the Medvoxel Heartpro Software Application import?

    The Medvoxel Heartpro Software Application can import pre-existing DICOM-compliant multi-phase and velocity-encoded MR images from PACS or scanners.

  • What is the regulatory classification of the Medvoxel Heartpro Software Application?

    The Medvoxel Heartpro Software Application is classified as a Class II device with the product code LLZ.