Radiology AI Directory

FDA-cleared profile

QUIBIM Precision Prostate (qp-Prostate)

QUIBIM S.L.

Authorized purpose: Views, processes, and analyzes prostate MR images for trained professionals; it is not diagnostic and decisions should not rely solely on its results.

Prostate imaging
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: Views, processes, and analyzes prostate MR images for trained professionals; it is not diagnostic and decisions should not rely solely on its results.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Views, processes, and analyzes prostate MR images for trained professionals; it is not diagnostic and decisions should not rely solely on its results.

Evidence takeaway

Evidence from the reviewed source record: QIBA DWI/DCE digital-reference-object bench testing and clinical testing on named 1.5T and 3T Siemens, GE, and Philips systems; datasets varied by component and no single device-level performance value applies.

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
Views, processes, and analyzes prostate MR images for trained professionals; it is not diagnostic and decisions should not rely solely on its results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.

Intended users
Radiologists specialized in prostate imaging, urologists, and oncologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA packet intended-user statement.

Care setting and population
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Confirm the intended care setting, patient population, and service line.

Workflow role
Detection, localization, or diagnostic support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
DICOM prostate MR with T2 plus DWI, T2 plus DCE, or T2+DWI+DCE workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA packet input scope.

Output and human action
ADC and perfusion maps, automated prostate segmentation, DICOM viewing and analysis, and structured PI-RADS v2.1 reporting with user verification and editing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA packet output scope.

Limitations
Sequence and protocol availability gates plug-ins, trained-user interpretation is required, and the device is not a diagnostic function.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

Exact FDA limitation boundary.

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
K203582
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA prostate MRI scope.

Anatomy
Prostate
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

Exact FDA prostate scope.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-02-04
  • 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 exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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
  • 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 2026-09-09

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 2026-09-09

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 2026-09-09

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

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for QUIBIM Precision Prostate (qp-Prostate); FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
QIBA DWI/DCE digital-reference-object bench testing and clinical testing on named 1.5T and 3T Siemens, GE, and Philips systems; datasets varied by component and no single device-level performance value applies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

Submission-reported technical and clinical testing.

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.

qp-Prostate regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K203582
  • Samplen=157
  • IndependenceIndependence not established

K203582

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K203582 configuration was established in this review.

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

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 K203582. 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 2026-09-09

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
2026-09-20Last searched
24Fields reviewed
10Source 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, fda decision summary packet, 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 K203582: QUIBIM Precision Prostate (qp-Prostate)

    U.S. Food and Drug Administration - Published 2021-02-04 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. qp-Prostate model card (K203582)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K203582

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

    Scope: postmarketSafety

Research history

  1. K203582 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

Alternatives

Related tools to compare

FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

QP-Prostate CAD detects and marks suspected prostate lesions for clinically significant prostate cancer on bi-parametric T2-weighted and diffusion-weighted prostate MRI, returning...

Modality
MRI
Anatomy
Prostate
Decision
2025-03-18
Prostate imagingDetection and CADe
FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Prostate MR AI (VA10A) is a plug-in CADe/CADx aid for radiologists interpreting prostate MRI in adult men aged 40 years or older with suspected prostate cancer and no prior...

Modality
MRI
Anatomy
Prostate
Decision
2025-03-05
Prostate imagingDetection and CADe
FDA-cleared K233196

Medihub Prostate

JLK Inc.

Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related...

Modality
MRI
Anatomy
Prostate
Decision
2024-06-21
Prostate imagingQuantification and segmentation