FlightPlan for Liver

K210807

GE Medical Systems SCS · cleared 2021-10-22 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray angiography images of the liver.”

Algorithmdeep learning-based Liver Segmentation algorithm and non-deep learning Virtual Parenchyma Visualization algorithm

source quote (p.5)

“The deep learning-based Liver Segmentation algorithm that performs an automated segmentation of the entire liver on injected CBCT acquisitions. The outputted liver segmentation is an intermediate result that is used as a boundary for the second algorithm, Virtual Parenchyma Visualization (VPV). The non-deep learning Virtual Parenchyma Visualization algorithm that selectively displays, for visualization purposes, the estimated distal liver region adjacent to the distal parts of the computed skeleton of the vessel segmentation (Virtual Parenchyma) interactively from a user-determined reference point(s).”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

standards: NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard, ISO 13485

Bench

sample size not stated

endpoints: capabilities to selectively display vascular structures and estimated distal liver region; predefined acceptance criteria

Retrospective clinical

sample size not stated

endpoints: predefined acceptance criteria; helps physicians visualize and analyze 3D X-ray angiography images; can be used to estimate distal liver regions from a reference point; aids in the planning of embolization procedures in the liver, including the selection of embolization injection points

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:99042
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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98428
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, SCS, initiated 2025-09-05): "Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient dat" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97657
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 (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 (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 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).