510(k) · Cleared
ClearedLibby IAAA v1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyad Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 17, 2021 as substantially equivalent to K123970 (Pie Medical Imaging BV, 2013) after a 263-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Dec 17, 2021
- Review
- 263 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K941322 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK941322 Echo-ScanTomographic Tech · 1995
- 6 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 5 generations backK993394 Echo Scan, Easy ScanTomtec Imaging Systems GmbH · 1999
- 4 generations backK011582 Qcu Analytical Software PackageMedis Medical Imaging Systems BV · 2001
- 3 generations backK021495 QIVAPie Medical Imaging BV · 2002
- 2 generations backK092842 EchoplaqueIndec Systems, Inc. · 2010
- 1 generation backK123970 Caas IntravascularPie Medical Imaging BV · 2013
- This deviceK210931 Libby IAAA v1.0Dyad Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −6 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −5 | K993394 | Echo Scan, Easy Scan | Tomtec Imaging Systems GmbH | 1999 | — |
| −4 | K011582 | Qcu Analytical Software Package | Medis Medical Imaging Systems BV | 2001 | — |
| −3 | K021495 | QIVA | Pie Medical Imaging BV | 2002 | — |
| −2 | K092842 | Echoplaque | Indec Systems, Inc. | 2010 | — |
| −1 | K123970 | Caas Intravascular | Pie Medical Imaging BV | 2013 | — |
| 0 (this device) | K210931 | Libby IAAA v1.0 | Dyad Medical, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K123970 | Caas IntravascularSummary page 4…LLZ Regulatory Class II 3. Predicate Device Proprietary Name Pie Medical CAAS Intravascular Premarket Notification K123970 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 Regulation N… | 2013 |
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 26 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210931: Libby IAAA v1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210931
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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