Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
LiverMultiScan v5 (LMSv5)
Perspectum
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MRSystems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1(cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
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
- LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MRSystems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1(cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
- Intended users
- LiverMultiScan is intended for use by Perspectum trained operators. The output generated by LiverMultiScan is intended for interpretation by trained healthcare professionals.
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult and Pediatric
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Segmentation or contouring
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- MRI images or data involving Liver; consult the FDA labeling for exact protocol, series, and quality requirements.
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- Proton Density Fat Fraction in the liver (PDFF), Liver Iron Concentration in of the liver (LIC) and T1 corrected for liver iron concentration, scanner manufacturer and field strength (cT1),
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Exclusion criteria: non-DICOM 3.0 compliant data. Supported hardware: Unspecified. Scanner manufacturers: Unspecified. Slice thickness: 3mm - 10mm. MRI field strength: 1.50T;3.00T. Reconstruction kernel: Not Applicable
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- On-premise
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Supported acquisition environment
Supported hardware: Unspecified. Scanner manufacturers: Unspecified
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for LiverMultiScan v5 (LMSv5); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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
- Study type: Stand-Alone Performance. Reference standard: Unspecified
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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.
LiverMultiScan regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult and Pediatric
- Scopeexact submission
- Tested versionv5.1
- IndependenceIndependence not established
K213960
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K213960 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K213960. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K213960 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
23Fields reviewed
9Source classes checked
20Awaiting review PubMed leads
10Awaiting review trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. 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 20 PubMed and 10 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, acr ai central product, 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
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FDA K213960: LiverMultiScan v5 (LMSv5)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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LiverMultiScan model card (K213960)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K213960
Scope: postmarketSafety
Research history
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K213960 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
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