LVivo Software Application
K161382DIACARDIO, LTD. · cleared 2016-07-28 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation.”
source quote (p.4)
“The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain. Image segmentation”
Validation studies (1)
Retrospective clinical
n=100 patients · 1 site(s)
endpoints: The primary end point defined for this study was met with a correlation coefficient calculated for biplane EF; Compare the strain results by LVivoSG to strain evaluated with VVI.; Compare the automated wall motion results by LVivoSG to wall motion evaluation by visual estimation.; Compare the global strain calculated by LVivoEF to the global strain calculated by LVivoSG.; show there is a good agreement between GLS calculated by both methods with correlation coefficient of r=0.8.
Reported performance (24 observations)
source quote (p.7)
“The agreement by kappa coefficient was also very good (kappa=0.77) and specificity and sensitivity were high (0.86 and 0.95 respectively) emphasizing the similarity between methods.”
source quote (p.7)
“The agreement by kappa coefficient was also very good (kappa=0.77) and specificity and sensitivity were high (0.86 and 0.95 respectively) emphasizing the similarity between methods.”
source quote (p.7)
“The accuracy indicated by AUC=0.86 was very good and the specificity and sensitivity were 0.8 and 0.78 respectively.”
source quote (p.7)
“Excellent inter-observer reliability between methods for GLS, was also demonstrated by intraclass correlation (ICC=0.92).”
source quote (p.7)
“The agreement by kappa coefficient was also very good (kappa=0.77)”
source quote (p.7)
“The agreement calculated by ICC was very good (ICC=0.86).”
source quote (p.7)
“The accuracy indicated by AUC=0.86 was very good and the specificity and sensitivity were 0.8 and 0.78 respectively.”
source quote (p.7)
“The accuracy indicated by AUC=0.86 was very good and the specificity and sensitivity were 0.8 and 0.78 respectively.”
source quote (p.8)
“Good agreement was demonstrated comparing territories of coronary arteries between strain by LVivoSG and strain by VVI with ICC =0.86, 0.84 and 0.9 for LAD, RCA and CX respectively.”
source quote (p.8)
“Good agreement was demonstrated comparing territories of coronary arteries between strain by LVivoSG and strain by VVI with ICC =0.86, 0.84 and 0.9 for LAD, RCA and CX respectively.”
source quote (p.8)
“Good agreement was demonstrated comparing territories of coronary arteries between strain by LVivoSG and strain by VVI with ICC =0.86, 0.84 and 0.9 for LAD, RCA and CX respectively.”
source quote (p.8)
“The best agreement was for CX with kappa=0.71 and specificity and sensitivity 0.8 and 0.94 respectively.”
source quote (p.8)
“The best agreement was for CX with kappa=0.71 and specificity and sensitivity 0.8 and 0.94 respectively.”
source quote (p.8)
“The best agreement was for CX with kappa=0.71 and specificity and sensitivity 0.8 and 0.94 respectively.”
source quote (p.8)
“The ICC comparing LAD, RCA and CX was 0.8, 0.82 and 0.83 respectively.”
source quote (p.8)
“The ICC comparing LAD, RCA and CX was 0.8, 0.82 and 0.83 respectively.”
source quote (p.8)
“The ICC comparing LAD, RCA and CX was 0.8, 0.82 and 0.83 respectively.”
source quote (p.8)
“The accuracy by AUC for LAD, RCA and CX was 0.86, 0.82 and 0.81 respectively.”
source quote (p.8)
“The accuracy by AUC for LAD, RCA and CX was 0.86, 0.82 and 0.81 respectively.”
source quote (p.8)
“The accuracy by AUC for LAD, RCA and CX was 0.86, 0.82 and 0.81 respectively.”
source quote (p.8)
“The level of agreement was 0.83 and specificity and sensitivity were 0.86 and 0.81 respectively.”
source quote (p.8)
“The level of agreement was 0.83 and specificity and sensitivity were 0.86 and 0.81 respectively.”
source quote (p.8)
“The level of agreement was 0.76 and specificity and sensitivity were 0.75 and 0.76 respectively.”
source quote (p.8)
“The level of agreement was 0.76 and specificity and sensitivity were 0.75 and 0.76 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).