Xeleris V Processing and Review System

K221680

GE Healthcare · cleared 2023-03-01 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.7)

“Xeleris V Processing and Review System is a Nuclear Medicine Software system that is designed for general nuclear medicine processing and review procedures for detection of radioisotope tracer uptake in the patient's body, using a variety of individual processing applications orientated to specific clinical applications.”

AlgorithmThe Q.Thera AI application performs radiation dose calculations per MIRD committee of SNM and ICRP Publication 89 guidelines, and uses automated organ segmentations from Q.Volumetrix MI for image pre-processing.

source quote (p.7)

“Image Pre-Processing: Q.Thera AI uses the predicate's Q.Volumetrix MI application for image pre-processing, bringing additional automated organ segmentations as well as enabling dosimetry on PET/CT imaging data. Dosimetry Calculations: Q.Thera AI adds calculation of radiation doses to Dosimetry Toolkit's previous determination of isotope residence time. Similar to the reference Olinda/EXM (K163687), the added calculations follow the guidelines published by the Medical Internal Radiation Dose (MIRD) committee of the Society of Nuclear Medicine (SNM) and models from publication № 89 of the International Commission on Radiological Protection (ICRP).”

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

endpoints: Safety; Effectiveness; Compliance with standards

standards: NEMA PS3.1 - 3.20, IEC62304, 21CFR 820, ISO 13485

Bench

sample size not stated

endpoints: Correctness of radiation doses

Bench

sample size not stated

endpoints: Similarity between derived planar images

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 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
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
…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).