Xeleris V Processing and Review Systems
K201103GE Healthcare · cleared 2020-09-25 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.10)
“Xeleris V introduces two new DL-based algorithms for: • Lung fissure segmentation as an alternative to the manual method. • Kidney segmentation as an enhancement to the non-DL automatic segmentation.”
source quote (p.10)
“Xeleris V introduces two new DL-based algorithms for: • Lung fissure segmentation as an alternative to the manual method. • Kidney segmentation as an enhancement to the non-DL automatic segmentation.”
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: algorithm performance; segmentation results scored using a 5-point Likert scale
standards: NEMA PS3.1 - 3.20, IEC62304, 21CFR 820, ISO 13485
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
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Healthcare, initiated 2025-02-19): "There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (C" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:96375
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Healthcare, initiated 2024-10-03): "GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a maliciou" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:95512
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Healthcare, initiated 2024-07-23): "Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the sam" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:95238
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K221680 (decision 2023-03-01) from GE Healthcare for a matching device line ("Xeleris V Processing and Review System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221680
- 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
- …and 21 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).