FDA-cleared profile
Quantib BV
Quantib Prostate is image post-processing software for processing, visualizing, and editing prostate MRI images. It supports registered multiparametric-MRI viewing, optional combined-image visualization, semi-automatic anatomical segmentation, volume computation, manual editing, and a structured PI-RADS workflow to assist trained medical professionals interpreting prostate MR studies; diagnosis should not be made solely from its analysis.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
The FDA indication identifies trained medical professionals; local credentialing, supervision, and competency requirements remain site-specific.
The FDA indication describes use in a clinical setting; inpatient, outpatient, screening, and service-line deployment boundaries require local confirmation.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
FDA-described DICOM compatibility does not prove compatibility with a specific local PACS, RIS, EHR, or orchestrator.
The deployment category is preserved from the prior exact-submission review; current commercial architecture requires confirmation.
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, encryption, vulnerability management, backup, and incident-response evidence.
The exact public materials do not establish a complete live monitoring protocol. Track exact software version, MRI sequence and quality, segmentation edits, ROI and PI-RADS overrides, failed studies, repeat work, routing failures, incidents, updates, and local diagnostic workflow impact.
Map the installed Quantib Prostate release, MRI sequences, anatomy, segmentation, measurements, PI-RADS workflow, and enabled functions to K202501 before acceptance.
exact submission · checked 2026-09-04Later Quantib product-family features are not evidence that this cleared release includes them.
The prior exact-submission review identifies an on-premise deployment category for the Quantib AI Node extension on off-the-shelf hardware. Confirm the current hosting region, data flow, system sizing, commercial configuration, and service boundary with the vendor.
exact submission · checked 2026-09-04The prior deployment category does not establish current hosting contracts, security controls, uptime, or local qualification.
The exact FDA material describes DICOM-compatible prostate MRI data and a PACS/image-post-processing workflow. Confirm interface versions, patient identity, sequence mapping, PACS/RIS/EHR compatibility, routing, storage, report behavior, and downtime handling locally.
exact submission · checked 2026-09-04Test representative identifiers, sequence mapping, orientation, overlays, measurements, routing, failure handling, and round trips locally.
Use a signed local test set for the labeled prostate MR workflow. Include common and difficult studies, sequence variation, low-quality or incomplete inputs, segmentation edits, ROI and PI-RADS overrides, and downstream reporting effects. Diagnosis should not be made solely from the analysis. Trained users must review the registered images, segmentations, measurements, overlays, and PI-RADS workflow output, and edit the semi-automatic segmentation when needed. The exact cleared population is prostate MR studies; performance outside the labeled anatomy, sequences, data quality, and local workflow is unknown.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model license and recurring cost against net radiologist and technologist time after review, throughput, repeat work, reporting, infrastructure, interfaces, training, support, downtime, upgrades, and replacement costs.
product family · checked 2026-09-04No exact-product price was found in reviewed public material; productivity or value claims require local evidence.
Track exact software version, MRI sequence and quality, segmentation edits, ROI and PI-RADS overrides, failed studies, repeat work, routing failures, incidents, recalls, updates, and local diagnostic workflow impact.
exact submission · checked 2026-09-04Revalidate after material software, model, interface, protocol, or clinical-policy changes. Exact-identifier recall review does not exclude family-level signals.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
No exact-submission sensitivity endpoint with a verified threshold, population, tested version, and source was identified or promoted.
No exact-submission specificity endpoint with a verified threshold, population, tested version, and source was identified or promoted.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) decision evidence package with software verification and validation and clinical-use evaluation of semi-automatic prostate segmentation after trained-user correction. · Prostate multiparametric MRI studies within the K202501 labeled workflow.
exact submission · Tested version: Quantib Prostate configuration described in K202501 · Sponsor or vendor studyK202501
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and it does not establish autonomous diagnosis or patient outcomes.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
FDA materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, interfaces, infrastructure, and included support from the vendor.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis 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.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Four PubMed records and one trial record were screened. Two PubMed titles name Quantib Prostate, but none identifies the tested software version or links it to K202501; the remaining records are generic. No exact-product/version evidence was promoted, and all five candidates remain 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, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
Alternatives
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