FlightPlan for Embolization

K223490

GE Medical Systems SCS · cleared 2023-03-21 · product code LLZ · Radiology

FDA 510(k) summary for FlightPlan for Embolization (K223490)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
6
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“FlightPlan for Embolization is a post-processing, software-only application using 3D X-ray angiography images (CBCT) as input. It helps clinicians visualize vasculature to aid in the planning of endovascular embolization procedures throughout the body. A new option, called Al Segmentation, was developed from the modifications to the predicate device, GE HealthCare's FlightPlan for Embolization [K193261]. It includes two new algorithms. This Al Segmentation option is what triggered this 510(k) submission.”
AlgorithmDeep-Learning based automatic vessels extraction algorithm and Deep-Learning based root definition algorithm
source quote (p.6)
“The Al Segmentation option enabling both automatic segmentation of vasculature and automatic definition of the root point is based on two new algorithms: Deep-Learning based automatic vessels extraction algorithm and Deep-Learning based root definition algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

n=207 scans

endpoints: success rate for automatic vessels extraction; success rate for root definition algorithm

standards: NEMA PS 3.1 - 3.20, 21CFR 820, ISO 13485

Reader study (MRMC)

sample size not stated

endpoints: meeting pre-defined acceptance criteria; helping physicians in analysis of 3D X-ray angiography images; helping in planning of embolization procedures; helping in 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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
32
drift signals on this device
  • predicate_cohort_contagion

    K223490 shares predicate K041521 with K133649 (HEPATIC VCAR), whose product code JAK recorded 75 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K041521 sibling:K133649

  • predicate_cohort_contagion

    K223490 shares predicate K181403 with K243446 (3DXR), whose product code OWB recorded 100 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K181403 sibling:K243446

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • …and 26 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems SCS) — same firm and product code, not necessarily this device · 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 an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.

    recall event 99042 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

    recall event 98428 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

    recall event 98428 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

    recall event 98428 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-09-02.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code LLZ

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K223490