510(k) · Cleared
ClearedSegment CMR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medviso AB · LLZ System, Image Processing, Radiological
Cleared on Apr 5, 2017 as substantially equivalent to K090833 (Medviso, 2009) and 3 other predicates after a 153-day review. Its family tree reaches back 5 generations to 1990. 2 later devices descend from it.
- Decided
- Apr 5, 2017
- Review
- 153 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K900889 (1990). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK900889 Magnetic Resonance Diagnostic Device AccessoriesSiemens Medical Solutions USA, Inc. · 1990
- 4 generations backK973799 Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK061368 Diagnosoft HarpDiagnosoft, Inc. · 2006
- 2 generations backK100352 Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 2010
- 1 generation backK111833 VirtueDiagnosoft, Inc. · 2011
- This deviceK163076 Segment CMRMedviso AB · 2017
- Descendant · cites it directly · 0 of its ownK232007 CAAS MR SolutionsPie Medical Imaging BV · 2024
- Descendant · cites it directly · 0 of its ownK211611 QIR SuiteCasis Cardiac Simulation & Imaging Software · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900889 | Magnetic Resonance Diagnostic Device Accessories | Siemens Medical Solutions USA, Inc. | 1990 | — |
| −4 | K973799 | Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K061368 | Diagnosoft Harp | Diagnosoft, Inc. | 2006 | — |
| −2 | K100352 | Diagnosoft Harp Model 2.06 | Diagnosoft, Inc. | 2010 | — |
| −1 | K111833 | Virtue | Diagnosoft, Inc. | 2011 | — |
| 0 (this device) | K163076 | Segment CMR | Medviso AB | 2017 | — |
| +1 | K232007 | CAAS MR Solutions | Pie Medical Imaging BV | 2024 | — |
| +1 | K211611 | QIR Suite | Casis Cardiac Simulation & Imaging Software | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K090833 | SegmentSummary page 4…analysis software Classification Name: Class II – System, Image Processing Regulation Number: 892.2050 Product Code: LLZ 5.3 Predicate Device • Segment (K090833) Medviso AB Griffelvägen 3 224 67 Lund Sweden • CMRtools and plugins Ventricular tools and… | 2009 |
| * | K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsSummary page 4…ent (K090833) Medviso AB Griffelvägen 3 224 67 Lund Sweden • CMRtools and plugins Ventricular tools and Thalassemia tools (K073194) Cardiovascular Imaging Solutions Ltd 53 Cavendish Road London SW12 0BL UK • Virtue includ… | 2008 |
| * | K111833 | VirtueSummary page 4…tools (K073194) Cardiovascular Imaging Solutions Ltd 53 Cavendish Road London SW12 0BL UK • Virtue including module HARP (K111833, K100352) Myocardial solutions 1204 Village Market Pl 290 Morrisville, NC 27560 USA MEDVISO AB… | 2011 |
| * | K100352 | Diagnosoft Harp Model 2.06Summary page 4…(K073194) Cardiovascular Imaging Solutions Ltd 53 Cavendish Road London SW12 0BL UK • Virtue including module HARP (K111833, K100352) Myocardial solutions 1204 Village Market Pl 290 Morrisville, NC 27560 USA MEDVISO AB… | 2010 |
What descends from it? (2)
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 27 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K232007 (Pie Medical Imaging BV, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090833.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system…
Read the full statement (138 words)
Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR 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/K163076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163076: Segment CMR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163076
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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