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
Medihub Prostate
JLK Inc.
Authorized purpose: Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related measurements and reporting; patient-management decisions must not rely on the software alone.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related measurements and reporting; patient-management decisions must not rely on the software alone.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related measurements and reporting; patient-management decisions must not rely on the software alone.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Prostate Input: DICOM-compatible multiparametric prostate MRI data including T2-weighted, DWI, ADC, and DCE sequences; FDA performance data used Siemens 3T Vida and Skyra systems and T2 slice thicknesses of 3.5-5 mm, with patients aged 55 years and above.
- Who uses it? Intended users: Trained radiologists and urologists
- What does the software produce? Output: Semi-automatic prostate outline and total prostate volume; overlaid images, registered and combined multiparametric views, user-defined ROIs, manually entered PSA density, PI-RADS and other manual annotations, DWI/DCE graphs, and a structured report.
- What is its most important limitation? Key limitation: Not fully automatic and not a lesion-segmentation tool. Prostate volume is the semi-automatic measurement and requires user review; other annotations and measurements are manual. The user must confirm the final result, decisions must not rely on it alone, and the packet's validation is limited to Siemens 3T Vida/Skyra, specified T2 slice thickness, and tested patients aged 55 years and above.
Clinical takeaway
Clinical role: Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related measurements and reporting; patient-management decisions must not rely on the software alone.
Evidence takeaway
Evidence from the reviewed source record: FDA K233196 reports stand-alone prostate-region segmentation and reader-performance testing. The stand-alone clinical test used 114 T2 prostate MR images with ground truth from three expert radiologists; overall Dice was 0.928 (95% CI 0.925-0.931) and Hausdorff distance was 2.171 (95% CI 1.097-3.245). Reader Dice improvements with the algorithm were 0.156, 0.011, and 0.008 for the three radiologists. The FDA summary also describes Korea, US, and ProstateX test datasets and a mean-Dice criterion of 0.894.
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
- Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related measurements and reporting; patient-management decisions must not rely on the software alone.
- Intended users
- Trained radiologists and urologists
- Care setting and population
- Hospital
- Workflow role
- Post-acquisition prostate MRI review and analysis with semi-automatic contouring; the user edits, reviews, and confirms the prostate outline and performs the other annotations and measurements.
- Required input
- DICOM-compatible multiparametric prostate MRI data including T2-weighted, DWI, ADC, and DCE sequences; FDA performance data used Siemens 3T Vida and Skyra systems and T2 slice thicknesses of 3.5-5 mm, with patients aged 55 years and above.
- Output and human action
- Semi-automatic prostate outline and total prostate volume; overlaid images, registered and combined multiparametric views, user-defined ROIs, manually entered PSA density, PI-RADS and other manual annotations, DWI/DCE graphs, and a structured report.
- Limitations
- Not fully automatic and not a lesion-segmentation tool. Prostate volume is the semi-automatic measurement and requires user review; other annotations and measurements are manual. The user must confirm the final result, decisions must not rely on it alone, and the packet's validation is limited to Siemens 3T Vida/Skyra, specified T2 slice thickness, and tested patients aged 55 years and above.
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
- DICOM-compatible MRI input, browser access, and export or transfer of results are described. The packet does not establish a specific current PACS, RIS, EHR, interface version, or deployment configuration.
- 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.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Medihub Prostate; 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
- FDA K233196 reports stand-alone prostate-region segmentation and reader-performance testing. The stand-alone clinical test used 114 T2 prostate MR images with ground truth from three expert radiologists; overall Dice was 0.928 (95% CI 0.925-0.931) and Hausdorff distance was 2.171 (95% CI 1.097-3.245). Reader Dice improvements with the algorithm were 0.156, 0.011, and 0.008 for the three radiologists. The FDA summary also describes Korea, US, and ProstateX test datasets and a mean-Dice criterion of 0.894.
- 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.
Medihub Prostate regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K233196
- Samplen=114
- IndependenceIndependence not established
K233196
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 K233196 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 K233196. 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 K233196 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
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
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 K233196: Medihub Prostate
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Medihub Prostate model card (K233196)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K233196
Scope: postmarketSafety
Research history
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K233196 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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