510(k) · Cleared
ClearedHeartscan Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Morpheus Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 3, 2014 as substantially equivalent to K103565 (Medvoxel Systems, Inc., 2011) after a 70-day review. Its family tree reaches back 4 generations to 2001. 10 later devices descend from it.
- Decided
- Mar 3, 2014
- Review
- 70 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010938 (2001). 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 3 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 2 generations backK042203 Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004
- 1 generation backK103565 Medvoxel Heartpro Software ApplicationMedvoxel Systems, Inc. · 2011
- This deviceK133937 Heartscan SoftwareMorpheus Imaging, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK162513 Arterys Software v2.0Arterys, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK163253 Arterys Cardio DLArterys, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK182034 Arterys MICAArterys, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK162376 CAAS MR 4D FlowPie Medical Imaging BV · 2016
- Descendant · 4 generations on · 2 of its ownK192437 Arterys MICAArterys, Inc. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K162513Arterys Software v2.0Arterys, Inc. · 2016 · cites it directly5descendants
- K163253Arterys Cardio DLArterys, Inc. · 2017 · 2 generations on4descendants
- K182034Arterys MICAArterys, Inc. · 2018 · 3 generations on3descendants
- K162376CAAS MR 4D FlowPie Medical Imaging BV · 2016 · cites it directly3descendants
- K192437Arterys MICAArterys, Inc. · 2020 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −3 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −2 | K042203 | Leonardo Syngo Cardiology Workstation | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −1 | K103565 | Medvoxel Heartpro Software Application | Medvoxel Systems, Inc. | 2011 | — |
| 0 (this device) | K133937 | Heartscan Software | Morpheus Imaging, Inc. | 2014 | — |
| +1 | K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016 | — |
| +2 | K163253 | Arterys Cardio DL | Arterys, Inc. | 2017 | — |
| +3 | K182034 | Arterys MICA | Arterys, Inc. | 2018 | — |
| +1 | K162376 | CAAS MR 4D Flow | Pie Medical Imaging BV | 2016 | — |
| +4 | K192437 | Arterys MICA | Arterys, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103565 | Medvoxel Heartpro Software ApplicationSummary page 1…egally Marketed Predicate Devices The Morpheus HeartScan software device is substantially equivalent to the MedVoxel Systems Inc. Med Voxel HeartPro Software System (K 103565). B. Device Description: Morpheus HeartScan is a web-accessible image analysis software application. The application is i… | 2011 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K162513 (Arterys, Inc., 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan 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 1.5T and 3.0 T MR Scanners. The data produced by…
Read the full statement (128 words)
HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan 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 1.5T and 3.0 T MR Scanners. The data produced by HeartScan 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/K133937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133937: Heartscan Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133937
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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