CaRi-Plaque
K242240Caristo Diagnostics Ltd. · cleared 2025-02-20 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“CaRi-Plaque v1.0 ("CaRi-Plaque,” the subject device) is a web-based software-only application for the quantitative and qualitative clinical analysis of previously acquired CCTA DICOM data for the purpose of characterizing and quantifying plaque formation and stenosis in coronary arteries.”
source quote (p.6)
“The third difference is that the methods of developing segmentation and plaque calculation algorithms differ for the subject versus the predicate device, as the subject device uses threshold-based segmentation while the predicate device uses machine learning to train the algorithms.”
source quote (p.6)
“The third difference is that the methods of developing segmentation and plaque calculation algorithms differ for the subject versus the predicate device, as the subject device uses threshold-based segmentation while the predicate device uses machine learning to train the algorithms.”
Validation studies (2)
Bench
sample size not stated
Retrospective clinical
n=117 patients · 4 site(s)
endpoints: plaque characteristics reported with CaRi-Plaque to ground truth determined by qualified independent medical experts; agreement between the expert readers and the CaRi-Plaque device measurements for Maximum Stenosis, Total Plaque Volume, Calcified Plaque Volume and Noncalcified Plaque Volume; agreement for Plaque Burden, Low Density Noncalcified Plaque Volume and Remodeling Index
Reported performance (4 observations)
source quote (p.9)
“Remodeling Index was assessed using Cohen's Kappa with an agreement of 63.3% (K = 0.42).”
source quote (p.9)
“Agreement between the expert readers and the CaRi-Plaque device measurements at the branch level were reported using Pearson Correlation Coefficients (or Cohen's Kappa for remodeling index). For RCA, R-PDA and R-PLB: Maximum Stenosis, Total Plaque Volume, Calcified Plaque Volume, Noncalcified Plaque Volume, Plaque Burden, Low Density Noncalcified Plaque Volume and Remodeling Index were 0.863, 0.958, 0.964, 0.953, 0.924, 0.633, 90.3% (K=0.31), respectively.”
source quote (p.9)
“For LAD, D1, D2 and Ramus: Maximum Stenosis, Total Plaque Volume, Calcified Plaque Volume, Noncalcified Plaque Volume, Plaque Burden, Low Density Noncalcified Plaque Volume and Remodeling Index were 0.929, 0.959, 0.997, 0.942, 0.913, 0.802, 87.2% (K=0.44), respectively.”
source quote (p.9)
“For LCX, OM1 and OM2: Maximum Stenosis, Total Plaque Volume, Calcified Plaque Volume, Noncalcified Plaque Volume, Plaque Burden, Low Density Noncalcified Plaque Volume and Remodeling Index were 0.911, 0.948, 0.991, 0.934, 0.888, 0.633, 90.3% (K=0.31), respectively.”
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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
- …and 20 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).