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. · QIH Automated Radiological Image Processing Software
Cleared on Jun 29, 2026 as substantially equivalent to K240791 (Adas3D Medical S.L., 2024) after a 200-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Jun 29, 2026
- Review
- 200 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K940172 (1994). 24 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 7 generations between
- 3 generations backK212421 ADAS 3DAdas3D Medical S.L. · 2021
- 2 generations backK230803 ADAS 3DAdas3D Medical S.L. · 2023
- 1 generation backK240791 ADAS 3DAdas3D Medical S.L. · 2024
- This deviceK253969 ADAS 3DAdas3D Medical S.L. · 2026
Show all 11 generations
- Root · 11 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 10 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 9 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 8 generations backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- 7 generations backK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- 6 generations backK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- 5 generations backK191125 ADAS 3DGalgo Medical S.L · 2020
- 4 generations backK210850 ADAS 3DAdas3D Medical S.L. · 2021
- 3 generations backK212421 ADAS 3DAdas3D Medical S.L. · 2021
- 2 generations backK230803 ADAS 3DAdas3D Medical S.L. · 2023
- 1 generation backK240791 ADAS 3DAdas3D Medical S.L. · 2024
- This deviceK253969 ADAS 3DAdas3D Medical S.L. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −10 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −9 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −8 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| −7 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| −6 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| −5 | K191125 | ADAS 3D | Galgo Medical S.L | 2020 | — |
| −4 | K210850 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
| −3 | K212421 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
| −2 | K230803 | ADAS 3D | Adas3D Medical S.L. | 2023 | — |
| −1 | K240791 | ADAS 3D | Adas3D Medical S.L. | 2024 | — |
| 0 (this device) | 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 |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K240791 | ADAS 3DSummary page 5…Secondary product code: LLZ REGULATION DESCRIPTION: Medical image management and processing system PREDICATE DEVICE: ADAS 3D (K240791) 29-06-2026 V.1.4 510(k) Summary 2 Device Des… | 2024 |
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 32 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 24 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
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 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…
Read the full statement (216 words)
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the
heart 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.
ADAS 3D is not intended for radiotherapy treatment planning, dose calculation, or treatment delivery. The DICOM RT
Structure Set (RTSTRUCT) export functionality is provided solely for interoperability and standardized exchange of
anatomical contour information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253969 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253969: ADAS 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253969
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026