510(k) · Cleared
ClearedEchoplaque
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indec Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 1, 2010 as substantially equivalent to K021495 (Pie Medical Imaging BV, 2002) and 1 other predicate after a 167-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 1, 2010
- Review
- 167 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K941322 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK941322 Echo-ScanTomographic Tech · 1995
- 4 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 3 generations backK993394 Echo Scan, Easy ScanTomtec Imaging Systems GmbH · 1999
- 2 generations backK011582 Qcu Analytical Software PackageMedis Medical Imaging Systems BV · 2001
- 1 generation backK021495 QIVAPie Medical Imaging BV · 2002
- This deviceK092842 EchoplaqueIndec Systems, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK123970 Caas IntravascularPie Medical Imaging BV · 2013
- Descendant · 2 generations on · 0 of its ownK210931 Libby IAAA v1.0Dyad Medical, Inc. · 2021
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 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −4 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −3 | K993394 | Echo Scan, Easy Scan | Tomtec Imaging Systems GmbH | 1999 | — |
| −2 | K011582 | Qcu Analytical Software Package | Medis Medical Imaging Systems BV | 2001 | — |
| −1 | K021495 | QIVA | Pie Medical Imaging BV | 2002 | — |
| 0 (this device) | K092842 | Echoplaque | Indec Systems, Inc. | 2010 | — |
| +1 | K123970 | Caas Intravascular | Pie Medical Imaging BV | 2013 | — |
| +2 | K210931 | Libby IAAA v1.0 | Dyad Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K021495 | QIVASummary page 1…icture Archiving and Communication System, Class II Sec. 21 CFR 807.92 Predicate Devices: QIVA Intra Vascular Ultrasound Analysis software (K021495) QCU-CMS Analytical Software Package (KOl 1582) Description of the Device: echoPlaque is a software product that pr… | 2002 |
| * | K011582 | Qcu Analytical Software Package | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123970 | Caas Intravascular | 2013 | 1 |
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 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K123970 (Pie Medical Imaging BV, 2013) has gone furthest, with 1 descendant 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. 2010, 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?
echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPiaque…
Read the full statement (109 words)
echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPiaque supports linear, area, and volumetric measurements. Measurements can be exported and images can be saved using echoPlaque. Images can be saved in either a compressed or uncompressed format. These features aid in post-procedure analysis regarding the placement of interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092842 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092842: Echoplaque.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092842
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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