Radiology AI Directory

FDA-cleared profile

Quantib Prostate

Quantib BV

Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume computation, and PI-RADS workflow support for prostate MRI. The software provides information that may assist trained medical professionals in interpreting prostate MR studies, and diagnosis must not be made solely from its analysis.

Prostate imagingQuantification 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
Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume computation, and PI-RADS workflow support for prostate MRI. The software provides information that may assist trained medical professionals in interpreting prostate MR studies, and diagnosis must not be made solely from its analysis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained medical professionals interpreting prostate MR studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Prostate MRI interpretation and reporting workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Multiparametric-MRI viewing, registration, prostate and sub-region segmentation, lesion review, PI-RADS workflow, and report generation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Prostate multiparametric MRI datasets and user-confirmed or edited segmentation and ROI inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Registered and combined MR views, prostate and sub-region segmentations, volume computations, PI-RADS properties, PDF reports, DICOM RT Structure Sets, and DICOM segmentation objects.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Outer segmentation and ROI location require inspection, editing, and confirmation; diagnosis must not be made solely from Quantib Prostate analysis and individual sub-region volumes are not provided.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K221106
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Prostate; prostate and prostatic sub-regions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-05-13
  • 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 FDA package describes multiparametric MRI input, manual editing and confirmation of prostate segmentation and ROI location, PDF report output, DICOM RT Structure Set output, and DICOM segmentation storage output.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.

Deployment and data flow
The FDA summary states that deployment and compatibility with the environment and other devices are equivalent to the previously cleared predicate; current site topology, interfaces, hosting, security, availability, and service remain unverified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the release-level boundary described in the exact FDA package; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only trained medical professionals interpreting prostate mr studies should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K221106 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Outer segmentation and ROI location require inspection, editing, and confirmation; diagnosis must not be made solely from Quantib Prostate analysis and individual sub-region volumes are not provided.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is buyer-facing monitoring guidance derived from the exact cleared or authorized scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K221106 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared or authorized release includes them.

Source

Deployment boundary

The FDA summary states that deployment and compatibility with the environment and other devices are equivalent to the previously cleared predicate; current site topology, interfaces, hosting, security, availability, and service remain unverified.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The FDA package describes multiparametric MRI input, manual editing and confirmation of prostate segmentation and ROI location, PDF report output, DICOM RT Structure Set output, and DICOM segmentation storage output.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Outer segmentation and ROI location require inspection, editing, and confirmation; diagnosis must not be made solely from Quantib Prostate analysis and individual sub-region volumes are not provided.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K221106 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Outer segmentation and ROI location require inspection, editing, and confirmation; diagnosis must not be made solely from Quantib Prostate analysis and individual sub-region volumes are not provided.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. prostate MRI image-post-processing software limits remain submission-specific.

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
K221106 FDA decision material identifies the exact prostate MRI image-post-processing software, labeled use, and submission-specific verification or approval evidence. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation beyond the exact evidence summarized here.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

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

K221106 FDA evidence package for Quantib Prostate

  • DesignSpecial 510(k) bench and qualitative clinical performance testing for prostate sub-region segmentation and PI-RADS sector-map ROI initialization.
  • PopulationProstate; prostate and prostatic sub-regions
  • Scopeexact submission
  • Tested versionQuantib Prostate version 2.0 described in K221106
  • IndependenceSponsor or vendor study

K221106

Bench testing used Dice overlap and mean surface distance; the clinical test used a five-point Likert scale with radiologist review, but the public summary does not expose sample counts or numeric scores.

Source

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price for the exact cleared or authorized configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging or clinical service line and verify payer, site-of-service, coding, and coverage assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K221106 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

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.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
12Source classes checked
4Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

Four PubMed records and one trial record were screened. Three publications and the trial use or discuss Quantib Prostate, but none identifies the tested software as version 2.0 from K221106; the review article is not exact-product performance evidence, so all five records are quarantined. The current discovery snapshot contains 4 PubMed and 1 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 decision material, fda pma record, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 510(k) K221106: Quantib Prostate

    U.S. Food and Drug Administration - Published 2022-05-13 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Quantib Prostate model card (K221106)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: anatomy

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K221106 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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