510(k) · Cleared
ClearedQcu Analytical Software Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LLZ System, Image Processing, Radiological
Cleared on Jul 31, 2001 as substantially equivalent to K993394 (Tomtec Imaging Systems GmbH, 1999) after a 69-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.
- Decided
- Jul 31, 2001
- Review
- 69 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941322 (1995). 8 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK941322 Echo-ScanTomographic Tech · 1995
- 2 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 1 generation backK993394 Echo Scan, Easy ScanTomtec Imaging Systems GmbH · 1999
- This deviceK011582 Qcu Analytical Software PackageMedis Medical Imaging Systems BV · 2001
- Descendant · cites it directly · 3 of its ownK022940 IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl · 2002
- Descendant · cites it directly · 3 of its ownK021495 QIVAPie Medical Imaging BV · 2002
- Descendant · cites it directly · 2 of its ownK092842 EchoplaqueIndec Systems, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK123970 Caas IntravascularPie Medical Imaging BV · 2013
- Descendant · 2 generations on · 1 of its ownK041581 Compacs, Version 1.0Intelligent Images Srl · 2004
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K022940IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl · 2002 · cites it directly3descendants
- K021495QIVAPie Medical Imaging BV · 2002 · cites it directly3descendants
- K092842EchoplaqueIndec Systems, Inc. · 2010 · cites it directly2descendants
- K123970Caas IntravascularPie Medical Imaging BV · 2013 · 2 generations on1descendant
- K041581Compacs, Version 1.0Intelligent Images Srl · 2004 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −2 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −1 | K993394 | Echo Scan, Easy Scan | Tomtec Imaging Systems GmbH | 1999 | — |
| 0 (this device) | K011582 | Qcu Analytical Software Package | Medis Medical Imaging Systems BV | 2001 | — |
| +1 | K022940 | IN-Vision View with Measurements Module, Model 1.0 | Intelligent Images Srl | 2002 | — |
| +1 | K021495 | QIVA | Pie Medical Imaging BV | 2002 | — |
| +1 | K092842 | Echoplaque | Indec Systems, Inc. | 2010 | — |
| +2 | K123970 | Caas Intravascular | Pie Medical Imaging BV | 2013 | — |
| +2 | K041581 | Compacs, Version 1.0 | Intelligent Images Srl | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K993394 | Echo Scan, Easy ScanSummary page 1…package Common Name : QCU-CMS Device Class. Name : System, Image Processing Regulation Number : 21 CFR 892.1560 (90 LLZ; Class Il) 3) Predicate Device : TomTec: 510(k) K993394 4) Description of the device: QCU-CMS is a state-of-the-art analytical software tool designed for Windows NT operating systems.… | 1999 |
What descends from it? (8)
4 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 6 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K022940 (Intelligent Images Srl, 2002) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K993394.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
QCU has been developed for the objective and reproducible analysis of tomograhic images of both lumen and arterial wall of a coronary or vascular segment, in particular the assessment of a stenosis or atherosclerotic plaque. This information supports the possible placement of intervention devices in these vessels. QCU-CMS enables an advanced assessment of vessel, lumen, and stent morphology. It also avoids the very time-consuming conventional manual…
Read the full statement (172 words)
QCU has been developed for the objective and reproducible analysis of tomograhic images of both lumen and arterial wall of a coronary or vascular segment, in particular the assessment of a stenosis or atherosclerotic plaque. This information supports the possible placement of intervention devices in these vessels. QCU-CMS enables an advanced assessment of vessel, lumen, and stent morphology. It also avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intra- and inter observer variability. QCU-CMS can be used to control stent placement and to assess in-stent restenosis. QCU software package enables the automatically calculation and the display of various parameters such as: areas and diameters in individual slices: volumes over the segment of interest (Simpson’s Rule) for the vessel, lumen and stent contours; plaque and in-stent restenosis parameters.
QCU-CMS analytical software is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of ultrasound images. When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011582: Qcu Analytical Software Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011582
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026