510(k) · Cleared
ClearedMedvoxel Heartpro Software Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medvoxel Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 12, 2011 as substantially equivalent to K042203 (Siemens Medical Solutions USA, Inc., 2004) after a 127-day review. Its family tree reaches back 3 generations to 2001. 11 later devices descend from it.
- Decided
- Apr 12, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010938 (2001). 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 2 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 1 generation backK042203 Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004
- This deviceK103565 Medvoxel Heartpro Software ApplicationMedvoxel Systems, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK133937 Heartscan SoftwareMorpheus Imaging, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK162513 Arterys Software v2.0Arterys, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK163253 Arterys Cardio DLArterys, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK182034 Arterys MICAArterys, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK162376 CAAS MR 4D FlowPie Medical Imaging BV · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K133937Heartscan SoftwareMorpheus Imaging, Inc. · 2014 · cites it directly10descendants
- K162513Arterys Software v2.0Arterys, Inc. · 2016 · 2 generations on5descendants
- K163253Arterys Cardio DLArterys, Inc. · 2017 · 3 generations on4descendants
- K182034Arterys MICAArterys, Inc. · 2018 · 4 generations on3descendants
- K162376CAAS MR 4D FlowPie Medical Imaging BV · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −2 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −1 | K042203 | Leonardo Syngo Cardiology Workstation | Siemens Medical Solutions USA, Inc. | 2004 | — |
| 0 (this device) | K103565 | Medvoxel Heartpro Software Application | Medvoxel Systems, Inc. | 2011 | — |
| +1 | K133937 | Heartscan Software | Morpheus Imaging, Inc. | 2014 | — |
| +2 | K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016 | — |
| +3 | K163253 | Arterys Cardio DL | Arterys, Inc. | 2017 | — |
| +4 | K182034 | Arterys MICA | Arterys, Inc. | 2018 | — |
| +2 | K162376 | CAAS MR 4D Flow | Pie Medical Imaging BV | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K042203 | Leonardo Syngo Cardiology WorkstationSummary page 1…de Name 510(k) Submitter/Manufacturer 510(k) Number Date Cleared Leonardo Syngo Cardiology Siemens Medical Solutions Inc. K042203 September 24, Workstation (Argus) 51 Valley Stream Parkway 2004… | 2004 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133937 | Heartscan Software | 2014 | 10 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K133937 (Morpheus Imaging, Inc., 2014) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K042203.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
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…
Read the full statement (128 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103565: Medvoxel Heartpro Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103565
Report an extraction error
Are you the manufacturer?
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