510(k) · Cleared
ClearedProFuse CAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eigen · LLZ System, Image Processing, Radiological
Cleared on Nov 21, 2018 as substantially equivalent to K041286 (Mri Devices Corp., 2004) and 2 other predicates after a 349-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Nov 21, 2018
- Review
- 349 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K954678 (1996). 37 ancestors in all, the oldest K913475 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 2 generations backK031779 CadstreamConfirma, Inc. · 2003
- 1 generation backK041286 Dynacad V1.0Mri Devices Corp. · 2004
- This deviceK173744 ProFuse CADEigen · 2018
- Descendant · cites it directly · 0 of its ownK191278 Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix) · 2019
Most influential descendants
Showing 1 of 1 · See all- K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix) · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −2 | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| −1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| 0 (this device) | K173744 | ProFuse CAD | Eigen | 2018 | — |
| +1 | K191278 | Rsi-Mri+ | Multimodal Imaging Services Corporation (Dba Healthlytix) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041286 | Dynacad V1.0Summary page 7…Devices DynaCAD V1.0 iCAD (K041286) (K091529) ProFuse… | 2004 |
| * | K091529 | Icad Veralook CTC Cad SoftwareSummary page 7…V1.0 iCAD (K041286) (K091529) ProFuse (K121517) (K120187) Properties… | 2010 |
| * | K121517 | Versavue Enterprise SuiteSummary page 7…(K041286) (K091529) ProFuse (K121517) (K120187) Properties Primary Referenced Referenced ProFuse CAD… | 2012 |
| † | K120187 | Multi-Modality Image Fusion | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191278 | Rsi-Mri+ | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 37 ancestors have a recall of any class.
- Of its descendants, K191278 (Multimodal Imaging Services Corporation (Dba Healthlytix), 2019) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K041286.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (327 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173744: ProFuse CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173744
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026