# K173744: ProFuse CAD

- Pathway: 510(k) (Traditional)
- Applicant: Eigen
- Decided: Nov 21, 2018 after 349 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: 6 generations back to K954678 (1996). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041286: Dynacad V1.0, Mri Devices Corp. (2004) Summary page 7.
- K091529: Icad Veralook CTC Cad Software, Icad, Inc. (2010) Summary page 7.
- K121517: Versavue Enterprise Suite, Icad, Inc. (2012) Summary page 7.

## Most influential descendants
- K191278: Rsi-Mri+ (2019), 0 descendants of its own

## Indications for use
ProFuse CAD is a post-processing software tool intended for viewing, analyzing, reviewing and reporting imaging files such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and Positron Emission Tomography (PET) studies. The software is able to process time series modality data acquired before, during, and after a contrast agent has been administered to the patient. The software allows a physician to evaluate tissue characteristics based on contrast enhancement visible on the time series. The time series data can also be processed to get subtraction image time –series with any reference time point. ProFuse CAD also provides capability to process a specialized MRI series called diffusion weighted imaging to evaluate tissue characteristics based on water diffusion. Some of the other posts –processing features include multi-planar reformats and registration between images. ProFuse CAD has a marking feature that allows the user to outline organs with minimal input and also annotate regions in the image in 3D. The software also allows for grading the annotated regions as defined by the user. After review, the software automatically generates a patient report that provides information like; organ volume, annotations; and grading along with automatically generated screenshots of the annotations in different images. Planned data from ProFuse CAD can be used for interventional procedures like MR – TRUS fusion biopsies. The data can be displayed on medical device data systems. ProFuse CAD is used as a tool to review and add to the results of interventional procedures like; adding pathology information when reviewing MR-TRUS fusion biopsy. When interpreted by a skilled physician, this device provides information that is intended to be used for screening, analysis, and interventional planning. Patient management decisions should not be made based solely on the results of ProFuse CAD. ProFuse CAD is intended to be used as an image viewer of multi-modality, digital images, including Ultrasound, CT, PET. ProFuse CAD is intended to be used in a variety of setting such as; medical offices, clinics, hospital, and home office.

Source page: https://510kreport.com/device/K173744
Methodology: https://510kreport.com/methodology