DICOM/PACS overlay workflow
The exact submission describes moderate/high suspicion lesion overlays returned in DICOM to third-party workstations and PACS.
exact submission · checked 2026-09-06FDA-cleared profile
QP-Prostate® CAD
Quibim S.L.
Authorized purpose: 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 moderate/high suspicion overlays in DICOM to third-party workstations/PACS for concurrent physician review; patient management must not rely on it 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: 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 moderate/high suspicion overlays in DICOM to third-party workstations/PACS for concurrent physician review; patient management must not rely on it alone.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: 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 moderate/high suspicion overlays in DICOM to third-party workstations/PACS for concurrent physician review; patient management must not rely on it alone.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Prostate Input: Bi-parametric prostate MRI consisting of T2-weighted and diffusion-weighted series from patients above 40 years; the FDA dataset includes 1.5T and 3T GE, Siemens, and Philips systems.
- Who uses it? Intended users: Properly trained physicians, including radiologists, urologists, and physicians qualified to interpret prostate MRI under PI-RADS practice
- What does the software produce? Output: Two-color overlay markings around suspected prostate lesions, distinguishing moderate and high suspicion for clinically significant cancer (Gleason score 7 or greater), returned in standard DICOM formats for third-party workstations and PACS.
- What is its most important limitation? Key limitation: Concurrent adjunctive support only; patient-management decisions should not be based solely on QP-Prostate CAD output.
Clinical takeaway
Clinical role: 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 moderate/high suspicion overlays in DICOM to third-party workstations/PACS for concurrent physician review; patient management must not rely on it alone.
Evidence takeaway
Evidence from the reviewed source record: Pivotal validation used 228 prostate MRI cases from multiple U.S. centers, with a nine-reader aided/unaided study; standalone lesion-level analysis included 247 lesions.
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
- 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 moderate/high suspicion overlays in DICOM to third-party workstations/PACS for concurrent physician review; patient management must not rely on it alone.
- Intended users
- Properly trained physicians, including radiologists, urologists, and physicians qualified to interpret prostate MRI under PI-RADS practice
- Care setting and population
- Adult prostate MRI; patients above 40 years of age
- Workflow role
- Concurrent detection and diagnostic support
- Required input
- Bi-parametric prostate MRI consisting of T2-weighted and diffusion-weighted series from patients above 40 years; the FDA dataset includes 1.5T and 3T GE, Siemens, and Philips systems.
- Output and human action
- Two-color overlay markings around suspected prostate lesions, distinguishing moderate and high suspicion for clinically significant cancer (Gleason score 7 or greater), returned in standard DICOM formats for third-party workstations and PACS.
- Limitations
- Concurrent adjunctive support only; patient-management decisions should not be based solely on QP-Prostate CAD output.
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 FDA submission describes standard DICOM overlays returned to third-party workstations and PACS; local PACS and fusion-biopsy compatibility require confirmation.
- Deployment and data flow
- On-premise
Baseline deployment category preserved; current hosting region, retention, and commercial configuration were not established.
- Security and privacy
- Vendor documentation pending
No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
- Training and support
- Vendor documentation pending
Current onboarding, competency, and support commitments were not established.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, update control, and drift review were not established.
Quibim family prostate workflow
Quibim's official QP-Prostate page describes prostate segmentation, lesion detection, PI-RADS structured reporting, DICOM, PACS, and fusion-biopsy integration; current exact K242683 compatibility and build require confirmation.
product family · checked 2026-09-07Evidence
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
- Pivotal validation used 228 prostate MRI cases from multiple U.S. centers, with a nine-reader aided/unaided study; standalone lesion-level analysis included 247 lesions.
- Reported sensitivity
- Standalone lesion-level sensitivity was 67.7% for high suspicion and 79.5% for high plus moderate suspicion in the FDA analysis.
- Reported specificity
- The FDA standalone analysis reported 0.417 false positives per case for high suspicion and 0.855 for high plus moderate suspicion; reader-study aided AUC was 0.868 versus 0.849 unaided.
Standalone AUC
0.732 AUC
- EndpointLesion-level prostate cancer detection
- Population247 lesions from 228 prostate MRI cases
- Tested versionQP-Prostate CAD submitted in K242683; build not stated
Reader-study aided AUC
0.868 AUC
- EndpointReader-study interpretation with QP-Prostate CAD aid
- Population228 cases interpreted by nine readers
- Tested versionQP-Prostate CAD submitted in K242683; build not stated
Reader-study AUC improvement
0.019 AUC difference
- EndpointAided versus unaided reader study
- Population228 cases interpreted by nine readers
- Tested versionQP-Prostate CAD submitted in K242683; build not stated
QP-Prostate CAD pivotal standalone and reader study
- DesignMulticenter standalone lesion analysis and nine-reader aided/unaided study
- Population228 prostate MRI cases from multiple U.S. centers; standalone analysis included 247 lesions and reader study used nine readers
- Scopeexact submission
- Tested versionQP-Prostate CAD submitted in K242683; build not stated
- Samplen=228
- IndependenceIndependence not established
K242683
Cases included biopsy/pathology or follow-up reference categories and 1.5T/3T systems from GE, Siemens, and Philips.
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 amount, range, currency, geography, or contract term was established.
- Reimbursement and coding
- Research pending
No payer or CMS policy review was performed in this worker cohort.
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
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
- Verify training: Current onboarding, competency, and support commitments were not established.
- Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
- Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, update control, and drift review were not established.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
26Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen is not a full paper review. 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, vendor product page, literature index, trial registry, 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
-
FDA 510(k) K242683: QP-Prostate CAD
Scope: identity, purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, deployment, evidenceSummary, evidenceMetrics, evidenceStudies
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
QP-Prostate® CAD model card (K242683)
Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, 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
-
QP-Prostate official product page
Scope: productFamilyWorkflow, implementationCapabilities
Research history
-
K242683 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
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
FDA-cleared K212783
ProstatID
ScanMed, LLC
Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or...
- Modality
- MRI
- Anatomy
- Prostate
- Decision
- 2022-07-08
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
FDA-cleared K221624
Avenda Health AI Prostate Cancer Planning Software
Avenda Health, Inc.
Adjunctive review of MR prostate images and biopsy findings for prostate segmentation, lesion evaluation, quantification, documentation, and pre-planning biopsy or...
- Modality
- MRI
- Anatomy
- Prostate
- Decision
- 2022-11-22