Illumeo System

K173588

Philips Medical Systems Technologies, Ltd. · cleared 2018-01-12 · product code LLZ · Radiology

FDA 510(k) summary for Illumeo System (K173588)

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
1
Cited predicates
3
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.3)
“Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Security and Privacy”

Validation studies (1)

Bench

sample size not stated

standards: ISO 14971, IEC 62304, IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices, NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM), Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

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

    K173588 shares predicate K162955 with K210831 (OnQ Neuro), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K162955 sibling:K210831

  • predicate_cohort_contagion

    K173588 shares predicate K162955 with K252261 (InferCare RECIST), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K162955 sibling:K252261

  • 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 (Philips Medical Systems Technologies Ltd. Matam Building 8/2 Advanced Technology Center Haifa Israel, initiated 2024-10-10): "A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens " Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:95604

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • …and 26 more.

Recalls attributed to this device

  • 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.

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

K251532

Mighty Oak Medical

cleared 2025-11-03

SurgiTwin

K250290

Twinsight

cleared 2025-08-29

Neuro Insight V1.0

K243681

Olea Medical S.A.S.

cleared 2025-07-23

GyriCalc (Version 1.0.0)

K250686

NeuroSpectrum Insights Corp.

cleared 2025-07-22

VersaViewer

K243651

GE Medical Systems SCS

cleared 2025-04-21

brAIn™ Shoulder Positioning

K243292

Avatar Medical

cleared 2025-03-20

aiCockpit AI Viewer

K241546

Fovia, Inc.

cleared 2025-02-26

QuickRad

K242838

Aikenist Technologies Pvt Ltd

cleared 2025-02-21

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K173588