AI4CMR v1.0
K220624AI4MedImaging Medical Solutions S.A. · cleared 2022-07-22 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“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.”
source quote (p.3)
“AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements.”
source quote (p.8)
“with ANSI AAMI IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, in addition to the FDA Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.””
Validation studies (2)
Bench
n=15 cases
endpoints: myocardial segmentation; End-diastolic volume (EDV); End-systolic volume (ESV); LV mass (LVM); Ejection Fraction (EF); Dice Similarity Coefficient (DSC); Intraclass Correlation Coefficient (ICC)
standards: ANSI AAMI IEC 62304:2006/A1:2016
Retrospective clinical
n=146 cases
endpoints: agreement; interrater variability (ICC); volumes; LV mass; Ejection Fraction
standards: ANSI AAMI IEC 62304:2006/A1:2016
Reported performance (12 observations)
source quote (p.8)
“For myocardium segmentation, an average dice similarity coefficient (DSC) of 0.72 per image was achieved.”
source quote (p.8)
“For LVM, EDV, ESV, and EF the intraclass correlation coefficient (ICC) was evaluated and the following performance was obtained: ... EDV ... 0.95”
source quote (p.8)
“For LVM, EDV, ESV, and EF the intraclass correlation coefficient (ICC) was evaluated and the following performance was obtained: ... ESV ... 0.99”
source quote (p.8)
“For LVM, EDV, ESV, and EF the intraclass correlation coefficient (ICC) was evaluated and the following performance was obtained: ... EF ... 0.99”
source quote (p.8)
“For LVM, EDV, ESV, and EF the intraclass correlation coefficient (ICC) was evaluated and the following performance was obtained: ... LVM ... 0.78”
source quote (p.9)
“AI4CMR vs consensus 0,992 0,980 8,663 0,990 0,98 0,99”
source quote (p.10)
“AI4CMR vs consensus 0,992 0,975 -2,893 0,991 0,99 0,99”
source quote (p.10)
“AI4CMR vs consensus 0,969 0,909 3,867 0,956 0,87 0,98”
source quote (p.11)
“AI4CMR vs consensus 0,956 0,936 2,452 0,955 0,94 0,97”
source quote (p.11)
“AI4CMR vs consensus 0,972 0,924 8,355 0,964 0,92 0,98”
source quote (p.12)
“AI4CMR vs consensus 0,967 0,888 -9,083 0,953 0,87 0,98”
source quote (p.12)
“AI4CMR vs consensus 0,902 0,712 7,802 0,814 0,15 0,93”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K252084 (decision 2026-02-11) from Ai4medimaging Medical Solutions S.A. for a matching device line ("AI4CMR v2.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252084
- adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
- …and 21 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).