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 uses automated organ segmentations for image pre-processing and dosimetry on PET/CT imaging data.
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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: Correctness of radiation doses; Similarity between derived planar images

standards: NEMA PS3.1 - 3.20, IEC62304, 21CFR 820, ISO 13485, MIRD committee of SNM, ICRP Publication 89

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
26
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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Healthcare) — same firm and product code, not necessarily this device · initiated 2026-01-16

    Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

    recall event 98368 (openFDA)

  • Recalling firm matches this device's applicant (GE Healthcare) — same firm and product code, not necessarily this device · 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 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

    recall event 96375 (openFDA)

  • Recalling firm matches this device's applicant (GE Healthcare) — same firm and product code, not necessarily this device · 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 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

    recall event 96375 (openFDA)

  • Recalling firm matches this device's applicant (GE Healthcare) — same firm and product code, not necessarily this device · 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 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

    recall event 96375 (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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K221680