Radiology AI Directory

FDA-cleared profile

MeVis Liver Suite

MeVis Medical Solutions AG

CT and MRI image analysis, segmentation, visualization, and volumetry for adult abdominal treatment planning and follow-up, including liver surgery, living-donor, transplant, and oncologic workflows; it is not a diagnostic viewer or PACS replacement.

Oncology quantificationQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
CT and MRI image analysis, segmentation, visualization, and volumetry for adult abdominal treatment planning and follow-up, including liver surgery, living-donor, transplant, and oncologic workflows; it is not a diagnostic viewer or PACS replacement.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists, surgeons, and radiologic technologists trained in abdominal image analysis and treatment planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Adult oncologic, living-donor, transplant, surgical-planning, and follow-up workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Interactive segmentation, visualization, volumetry, and surgical-strategy support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM CT and MR abdominal image series meeting the labeled protocol requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Two-dimensional and three-dimensional visualizations, organ and lesion segmentations, volumetry, vascular territories, margins, and separation proposals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The application is not a replacement for diagnostic review or PACS. AI-assisted semi-automatic tools have narrower labeled conditions, including restrictions described for healthy living-donor CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K232045
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Liver
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-10-27
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The cleared software imports DICOM CT and MR data and provides export options; MeVis describes the current family as vendor-neutral, but local interface compatibility requires qualification.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Current product-family workflow context

MeVis describes the current Liver Suite family as vendor-neutral CT and MRI DICOM analysis with interactive 2D/3D visualization, volumetry, surgical-strategy support, and export options.

product family ยท checked 2026-09-08

Confirm exact-release availability, interfaces, hosting, security, support, and commercial terms during procurement.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

No exact-version evidence summary has been curated yet.

Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K232045 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K232045. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-08Last searched
18Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA scope controls clinical claims. ACR and official vendor material provide bounded catalog or product-family context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, vendor product page, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K232045: MeVis Liver Suite

    U.S. Food and Drug Administration - Published 2023-10-27 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  6. openFDA exact recall query for K232045

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

  7. MeVis Liver Suite

    MeVis Medical Solutions AG - Accessed 2026-09-08

    Scope: productFamily, clinicalWorkflow, DICOM, implementationCapabilities

Research history

  1. K232045 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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