MeVis Liver Suite

K232045

MeVis Medical Solutions AG · cleared 2023-10-27 · product code JAK · Radiology

FDA 510(k) summary for MeVis Liver Suite (K232045)

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
1
Product code
JAK
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM).”
AlgorithmAI based semi-automatic pre-segmentation tools
source quote (p.3)
“In addition to the manual segmentation tools, MeVis Liver Suite provides AI based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein, and portal vein restricted to CT scans of potential living liver donors with healthy livers and intended for:”
Adaptive (vs locked)No
source quote (p.7)
“The semi-automatic pre-segmentation uses locked/non adaptive Al networks.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: DICE score; Hausdorff (HD) value; qualitative scoring (5-point Likert scale); accuracy of volume calculation; precision of volume calculation

Reported performance (1 observation)

diceas written: “DICE”0.98
source quote (p.16)
“MeVis Liver Suite achieved a mean and median DICE score > 85% with a median 95% Hausdorff (HD) value of <2.0 mm.”

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
216
MAUDE reports in code, 12mo
-12%
vs code's own 3-yr baseline
11
drift signals on this device
  • predicate_cohort_contagion

    K232045 shares predicate K133643 with K233209 (uOmnispace.CT), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K133643 sibling:K233209

  • predicate_cohort_contagion

    K232045 shares predicate K173420 with K201232 (Limbus Contour), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K173420 sibling:K201232

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98738

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98588

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98206

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97699

  • …and 5 more.

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 2026-08-26.

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 JAK

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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SOMATOM X.cite; SOMATOM X.ceed

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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/K232045