510(k) · Cleared
ClearedIvus Enhancer
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 Nov 22, 2006 as substantially equivalent to K022940 (Intelligent Images Srl, 2002) and 1 other predicate after a 54-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Nov 22, 2006
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K941322 (1995). No later device cites it as a predicate yet.
- 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 backK022940 IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl · 2002
- This deviceK062985 Ivus EnhancerIndec Systems, Inc. · 2006
View 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 | K022940 | IN-Vision View with Measurements Module, Model 1.0 | Intelligent Images Srl | 2002 | — |
| 0 (this device) | K062985 | Ivus Enhancer | Indec Systems, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K022940 | IN-Vision View with Measurements Module, Model 1.0Summary page 1…fication: Picture Archiving and Communication System, Class IISec. 21 CFR 807.92 Predicate Devices: In-Vision View with Measurements Module (K022940) QCU-CMS Analytical Software Package (K011582) Descriptionof the Device: IVUS Enhancer is a software product that pr… | 2002 |
| * | K011582 | Qcu Analytical Software PackageSummary page 1…tem, Class IISec. 21 CFR 807.92 Predicate Devices: In-Vision View with Measurements Module (K022940) QCU-CMS Analytical Software Package (K011582) Descriptionof the Device: IVUS Enhancer is a software product that provides capabilities for viewing and interactin… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 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.
- 1 other device also cites its predicate K022940.
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?
IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals review DICOM images by adjusting image properties, making simple measurements, and adding annotations for easy export to other applications. These features aid in post-procedure analysis after the placement of interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062985: Ivus Enhancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062985
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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