MR Diffusion Perfusion Mismatch V1.0
K223502Olea Medical · cleared 2023-01-13 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (PWI) and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps.”
source quote (p.6)
“MR Diffusion Perfusion Mismatch V1.0 uses a Diffusion Brain Extraction Tool (BET) and a Perfusion Background Segmentation step based on AI algorithms.”
Validation studies (1)
Retrospective clinical
n=30 cases
endpoints: Pearson and Spearman correlation coefficients for parametric maps (ADC, CBF, CBV, MTT, tMIP); Bland-Altman analysis for Volume_1 (average estimated bias, 95% measurement differences); Mean DICE index for Volume_1; Scatterplot linear regression (R2) for Volume_1; Bland-Altman analysis for Volume_2 (average estimated bias, 95% measurement differences); Mean DICE index for Volume_2; Scatterplot linear regression (R2) for Volume_2; Bland-Altman analysis for Mismatch Ratio (average estimated bias, 95% measurement differences, absolute mean of differences); Bland-Altman analysis for Mismatch Volume (average estimated bias, 95% measurement differences, absolute mean of differences); Bland-Altman analysis for Relative Mismatch (average estimated bias, 95% measurement differences, absolute mean of differences)
Reported performance (2 observations)
source quote (p.7)
“Mean DICE index (similarity coefficient) was excellent and equal to 0.96 between MR Diffusion Perfusion Mismatch V1.0 and Olea Sphere® V3.0 Volume_1 segmentations.”
source quote (p.8)
“The variability of Volume_2 between both devices was reflected by a 0.75 mean DICE index.”
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).