510(k) · Cleared
ClearedAI4CMR v2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ai4medimaging Medical Solutions S.A. · QIH Automated Radiological Image Processing Software
Cleared on Feb 11, 2026 as substantially equivalent to K220624 (Ai4medimaging Medical Solutions S.A., 2022) after a 224-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Feb 11, 2026
- Review
- 224 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945512 (1995). 18 ancestors in all, the oldest K945428 (1995). No later device cites it as a predicate yet.
- Root · 9 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 5 generations between
- 3 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 2 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 1 generation backK220624 AI4CMR v1.0Ai4medimaging Medical Solutions S.A. · 2022
- This deviceK252084 AI4CMR v2.0Ai4medimaging Medical Solutions S.A. · 2026
Show all 9 generations
- Root · 9 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 8 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 7 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 6 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 5 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 4 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 3 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 2 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 1 generation backK220624 AI4CMR v1.0Ai4medimaging Medical Solutions S.A. · 2022
- This deviceK252084 AI4CMR v2.0Ai4medimaging Medical Solutions S.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −8 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −7 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −6 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −5 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −4 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −3 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| −2 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| −1 | K220624 | AI4CMR v1.0 | Ai4medimaging Medical Solutions S.A. | 2022 | — |
| 0 (this device) | K252084 | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 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 23.5 · 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 |
|---|---|---|---|
| * | K220624 | AI4CMR v1.0Summary page 5…QIH, LLZ Regulatory Class II 3 Predicate and Reference Device Proprietary Name AI4CMR v1.0 (Predicate Device) Premarket Notification K220624 Common Name AI4CMR Classification Name Automated radiological image processing software Regulation Num… | 2022 |
| † | K242781 | cvi42 Software Application | 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 31 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K220624.
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?
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices, etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4CMR also supports clinical diagnostics by calculating flow measurements of vascular structures in 2D phase-encoded cardiac MR images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252084: AI4CMR v2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252084
Report an extraction error
Are you the manufacturer?
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