# K103565: Medvoxel Heartpro Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Medvoxel Systems, Inc.
- Decided: Apr 12, 2011 after 127 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010938 (2001). 3 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042203: Leonardo Syngo Cardiology Workstation, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K133937: Heartscan Software (2014), 10 descendants of its own
- K162513: Arterys Software v2.0 (2016), 5 descendants of its own
- K163253: Arterys Cardio DL (2017), 4 descendants of its own
- K182034: Arterys MICA (2018), 3 descendants of its own
- K162376: CAAS MR 4D Flow (2016), 3 descendants of its own

## Indications for use
HeartPro consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 15T and 3.0 T MR Scanners. The data produced by HeartPro is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Source page: https://510kreport.com/device/K103565
Methodology: https://510kreport.com/methodology