Radiology AI Directory

FDA-cleared profile

breastscape v1.0

Olea Medical

Authorized purpose: Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may support screening, diagnosis, and intervention planning, but patient management must not rely solely on the results.

Breast 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.

Product overview

Start with the essentials

Authorized purpose: Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may support screening, diagnosis, and intervention planning, but patient management must not rely solely on the results.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may support screening, diagnosis, and intervention planning, but patient management must not rely solely on the results.

Evidence takeaway

Evidence from the reviewed source record: Olea Medical reports extensive internal verification and validation covering product risk assessment, software-module verification, and software validation for the Olea Sphere V3.0 system. The packet also references a pivotal clinical study and additional comparisons with MultiView MR Breast for BreastLoc, direct manual measurements for BreastApp metrics and maps, and validation of reporting, follow-up, mammography loading, and visualization; no numeric sensitivity, specificity, AUC, Dice, or reader-delta endpoint is reported in the packet.

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
Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may support screening, diagnosis, and intervention planning, but patient management must not rely solely on the results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Trained breast imaging physicians and trained MRI technologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Hospitals, imaging centers, and radiologist reading practices.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Breast MRI visualization, semi-automatic lesion segmentation and measurement, kinetic analysis and reporting, follow-up review, and MR-guided interventional planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DCE-MRI breast image series in DICOM format accessed through Olea Sphere V3.0, with mammography and ultrasound series available for display-only viewing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Registered MR viewing, subtractions, kinetic curves and semi-quantitative maps, semi-automatic lesion segmentation, lesion volume and 2D/3D diameter, distances to nipple, chest, and skin, BI-RADS annotations and breast-sector localization, follow-up layouts, and BreastLoc outputs for needle block position, insertion point, introducer depth, and insertion-path display.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
breastscape V1.0 is not intended for primary interpretation of digital mammography. Lossy-compressed mammographic images and digitized film-screen images must not be used for primary interpretation. A skilled physician must interpret the information, and patient-management decisions must not be based solely on the results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K211431
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Breast lesions and breast morphological landmarks including nipple, chest, and skin borders.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-08-02
  • 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 device is an optional PACS module that requires the cleared Olea Sphere V3.0 PACS viewer (K152602), its data and license-management services, and operational use of that package. It accesses MR image series in DICOM format through Olea Sphere V3.0; a specific local PACS or RIS interface beyond that dependency is not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for breastscape v1.0; 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
Olea Medical reports extensive internal verification and validation covering product risk assessment, software-module verification, and software validation for the Olea Sphere V3.0 system. The packet also references a pivotal clinical study and additional comparisons with MultiView MR Breast for BreastLoc, direct manual measurements for BreastApp metrics and maps, and validation of reporting, follow-up, mammography loading, and visualization; no numeric sensitivity, specificity, AUC, Dice, or reader-delta endpoint is reported in the packet.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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.

breastscape v1.0 regulatory performance study summary

  • DesignUnspecified
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K211431
  • IndependenceIndependence not established

K211431

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 K211431 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 K211431. 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
23Fields reviewed
9Source 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, 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 K211431: breastscape v1.0

    U.S. Food and Drug Administration - Published 2021-08-02 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. breastscape v1.0 model card (K211431)

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

    Scope: intendedUsers, output, 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 K211431

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

    Scope: postmarketSafety

Research history

  1. K211431 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

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