510(k) · Cleared
ClearedSegment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medviso · LLZ System, Image Processing, Radiological
Cleared on May 12, 2009 as substantially equivalent to K994283 (Medis Medical Imaging Systems BV, 2000) and 1 other predicate after a 47-day review. Its family tree reaches back 3 generations to 1994. 13 later devices descend from it.
- Decided
- May 12, 2009
- Review
- 47 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940172 (1994). 5 ancestors in all, the oldest K924605 (1993). 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 2 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 1 generation backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- This deviceK090833 SegmentMedviso · 2009
- Descendant · cites it directly · 9 of its ownK111311 Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies) · 2011
- Descendant · 2 generations on · 7 of its ownK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- Descendant · 3 generations on · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · 5 generations on · 4 of its ownK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies) · 2011 · cites it directly9descendants
- K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014 · 2 generations on7descendants
- K151233MonacoImpac Medical Systems, Inc. · 2015 · 3 generations on6descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · 4 generations on5descendants
- K190178Monaco RTP SystemElekta, Inc. · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −2 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −1 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| 0 (this device) | K090833 | Segment | Medviso | 2009 | — |
| +1 | K111311 | Segmentation Assistant for Prostate-Auto Contouring | Omisa Inc. (Segasist Technologies) | 2011 | — |
| +2 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| +3 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| +4 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +5 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K994283 | Mri- Magnetic Resonance Analytical Software SystemSummary page 4…s currently on the market. Medviso AB considers the features of the Segment to be substantially equivalent to the subset of features in common with the MRI- MASS (510(k) 994283) and MRI-FLOW (510(k) 994282) MEDVISO AB Page 5-4 Thulehemsvagen 1… | 2000 |
| * | K994282 | Mri- Flow Analytical Software PackageSummary page 4…dviso AB considers the features of the Segment to be substantially equivalent to the subset of features in common with the MRI- MASS (510(k) 994283) and MRI-FLOW (510(k) 994282) MEDVISO AB Page 5-4 Thulehemsvagen 157… | 2000 |
What descends from it? (13)
See all 132 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 15 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K111311 (Omisa Inc. (Segasist Technologies), 2011) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K994283.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 is a software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Segment specifically analyzes the function of the heart and its major vessels using multi-slice, multi-frame and velocity encoded MR images. It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart such as left and right ventricular volumes, ejection fractions…
Read the full statement (182 words)
Segment is a software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Segment specifically analyzes the function of the heart and its major vessels using multi-slice, multi-frame and velocity encoded MR images. It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart such as left and right ventricular volumes, ejection fractions, stroke volumes, peak ejection and filling rates, myocardial mass, regional wall thickness, fractional thickening and wall motion. It also provides quantitative data on blood flow and velocity in the arterial vessels and at the heart valves. Segment is tested on MR images acquired from both 1.5 T and 3 T MR scanners. The data produced by Segment 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/K090833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090833: Segment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090833
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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