510(k) · Cleared
ClearedADAS 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adas3D Medical S.L. · LLZ System, Image Processing, Radiological
Cleared on Sep 3, 2021 as substantially equivalent to K210850 (Adas3D Medical S.L., 2021) after a 30-day review. Its family tree reaches back 8 generations to 1994. 3 later devices descend from it.
- Decided
- Sep 3, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K940172 (1994). 21 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 7 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 6 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 5 generations backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- 4 generations backK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- 3 generations backK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- 2 generations backK191125 ADAS 3DGalgo Medical S.L · 2020
- 1 generation backK210850 ADAS 3DAdas3D Medical S.L. · 2021
- This deviceK212421 ADAS 3DAdas3D Medical S.L. · 2021
- Descendant · cites it directly · 2 of its ownK230803 ADAS 3DAdas3D Medical S.L. · 2023
- Descendant · 2 generations on · 1 of its ownK240791 ADAS 3DAdas3D Medical S.L. · 2024
- Descendant · 3 generations on · 0 of its ownK253969 ADAS 3DAdas3D Medical S.L. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −7 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −6 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −5 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| −4 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| −3 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| −2 | K191125 | ADAS 3D | Galgo Medical S.L | 2020 | — |
| −1 | K210850 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
| 0 (this device) | K212421 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
| +1 | K230803 | ADAS 3D | Adas3D Medical S.L. | 2023 | — |
| +2 | K240791 | ADAS 3D | Adas3D Medical S.L. | 2024 | — |
| +3 | K253969 | ADAS 3D | Adas3D Medical S.L. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K210850 | ADAS 3DSummary page 4…ULATION DESCRIPTION: Picture archiving and communications system Medical image management and processing system PREDICATE DEVICE: ADAS 3D (K210850) 1. DEVICE DESCRIPTION ADAS 3D is a stand-alone software tool designed for post-processing cardiovascular enhanced Magnetic R… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230803 | ADAS 3D | 2023 | 2 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K230803 (Adas3D Medical S.L., 2023) has gone furthest, with 2 descendants 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. 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?
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease. ADAS 3D is indicated for patients with myocardial scar produced by ischemic or non-ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D. ADAS 3D is indicated…
Read the full statement (184 words)
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic or non-ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians) for the calculation, quantification and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212421 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212421: ADAS 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212421
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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