Radiology AI Directory

FDA-approved profile

QVCAD System

QView Medical, Inc.

The QVCAD System is indicated as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System, for screening mammography BI-RADS Assessment Category 1 or 2 and BI-RADS composition or density c or d, to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators are not intended for diagnostic characterization of suspicious findings.

Breast imagingDetection and CADeUltrasound workflow
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
The QVCAD System is indicated as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System, for screening mammography BI-RADS Assessment Category 1 or 2 and BI-RADS composition or density c or d, to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators are not intended for diagnostic characterization of suspicious findings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified readers of screening Automated Breast Ultrasound System studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Screening workflows using the somo.v Automated Breast Ultrasound System.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Aid to the reader while searching 3D automated breast-ultrasound images for mammography-occult lesions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Three-dimensional images of female breasts produced by the somo.v Automated Breast Ultrasound System.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Indicators for regions not known to have suspicious findings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The PMA approval statement limits use to specified screening BI-RADS categories and breast densities; indicators are not intended for diagnostic characterization of suspicious findings.
  • 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
P150043
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Female breasts; mammography-occult lesions in non-suspicious regions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
PMA
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2016-11-09
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-approved
  • 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 PMA record identifies the somo.v Automated Breast Ultrasound System as the source of the three-dimensional breast images; the current public PMA record does not establish broader interface, archive, or export behavior.
  • 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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

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 qualified readers of screening automated breast ultrasound system 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 P150043 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: The PMA approval statement limits use to specified screening BI-RADS categories and breast densities; indicators are not intended for diagnostic characterization of suspicious findings.
  • 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 P150043 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 exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

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 PMA record identifies the somo.v Automated Breast Ultrasound System as the source of the three-dimensional breast images; the current public PMA record does not establish broader interface, archive, or export behavior.

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. The PMA approval statement limits use to specified screening BI-RADS categories and breast densities; indicators are not intended for diagnostic characterization of suspicious findings.

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 P150043 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: The PMA approval statement limits use to specified screening BI-RADS categories and breast densities; indicators are not intended for diagnostic characterization of suspicious findings.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. PMA-authorized breast ultrasound computer-aided detection device 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
P150043 FDA decision material identifies the exact PMA-authorized breast ultrasound computer-aided detection device, 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.

P150043 FDA evidence package for QVCAD System

  • DesignOriginal PMA approval record and approval-order statement.
  • PopulationFemale breasts; mammography-occult lesions in non-suspicious regions
  • Scopeexact submission
  • Tested versionQVCAD System configuration described in P150043
  • IndependenceSponsor or vendor study

P150043

The PMA page warns that supplements may change device description or indication and lists supplement S001; this dossier is anchored to base PMA submission P150043 and does not infer supplement scope.

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 P150043 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
11Source classes checked
2Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Two PubMed records were screened. One identifies the QVCAD System but does not state a tested version or link the study to P150043, while the other does not establish the exact QVCAD configuration; both records are quarantined and none is promoted. The current discovery snapshot contains 2 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, 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 PMA P150043: QVCAD System

    U.S. Food and Drug Administration - Published 2016-11-09 - 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. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

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

    Scope: coverage, codingContext

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. P150043 FDA decision

    Regulatory record

    PMA

  2. Source-review record updated

    Research record

    human reviewed

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