Web and DICOM workflow
The exact submission describes manual or automated DICOM import, cloud-based processing, and display in the TumorSight web application on an off-the-shelf computer.
exact submission · checked 2026-09-06FDA-cleared profile
TumorSight Viz
SimBioSys, Inc.
Authorized purpose: TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction, segmentation, 3D renderings, measurements, kinetic curves, parametric maps, MIPs, and reformats for physician visualization and analysis; results are not the sole basis for patient management.
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: TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction, segmentation, 3D renderings, measurements, kinetic curves, parametric maps, MIPs, and reformats for physician visualization and analysis; results are not the sole basis for patient management.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction, segmentation, 3D renderings, measurements, kinetic curves, parametric maps, MIPs, and reformats for physician visualization and analysis; results are not the sole basis for patient management.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Breast Input: Dynamic contrast-enhanced breast MRI DICOM studies from patients with biopsy-proven invasive early-stage or locally advanced breast cancer; the FDA packet describes manual or automated DICOM import.
- Who uses it? Intended users: Skilled physicians and clinicians, including radiologists, interpreting breast MRI
- What does the software produce? Output: Registered and subtracted images, MIPs, reformats, kinetic curves, parametric maps, 3D tumor segmentation, tumor volume, tumor-to-breast ratio, longest dimension, tumor-to-nipple/skin/chest distances, and center of mass.
- What is its most important limitation? Key limitation: The output supports visualization and analysis but patient-management decisions should not be made solely from TumorSight Viz results.
Clinical takeaway
Clinical role: TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction, segmentation, 3D renderings, measurements, kinetic curves, parametric maps, MIPs, and reformats for physician visualization and analysis; results are not the sole basis for patient management.
Evidence takeaway
Evidence from the reviewed source record: Validation used 267 samples from 266 patients at more than eight U.S. sites, with pathologically confirmed invasive breast cancer and reference measurements from three board-certified radiologists.
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
- TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction, segmentation, 3D renderings, measurements, kinetic curves, parametric maps, MIPs, and reformats for physician visualization and analysis; results are not the sole basis for patient management.
- Intended users
- Skilled physicians and clinicians, including radiologists, interpreting breast MRI
- Care setting and population
- Adult breast oncology imaging for biopsy-proven early-stage or locally advanced breast cancer
- Workflow role
- Visualization, segmentation, and measurement support
- Required input
- Dynamic contrast-enhanced breast MRI DICOM studies from patients with biopsy-proven invasive early-stage or locally advanced breast cancer; the FDA packet describes manual or automated DICOM import.
- Output and human action
- Registered and subtracted images, MIPs, reformats, kinetic curves, parametric maps, 3D tumor segmentation, tumor volume, tumor-to-breast ratio, longest dimension, tumor-to-nipple/skin/chest distances, and center of mass.
- Limitations
- The output supports visualization and analysis but patient-management decisions should not be made solely from TumorSight Viz results.
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 device reads DICOM MRI and displays results in the TumorSight web application; image import can be manual or automated and results are accessed through an off-the-shelf computer.
- Deployment and data flow
- On-cloud
Baseline cloud deployment category preserved; current hosting region, retention, and tenant configuration were not established.
- Security and privacy
- Vendor documentation pending
No scoped current security or data-flow 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.
Current family visualization workflow
SimBioSys describes TumorSight Viz as DCE-MRI software with 3D visualization, auto-segmented tumor/anatomical structures, and measurements; its prone-to-supine feature is explicitly described as research-use only.
product family · checked 2026-09-07Current family page is not used to promote unvalidated features into the exact K251766 performance record.
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
- Validation used 267 samples from 266 patients at more than eight U.S. sites, with pathologically confirmed invasive breast cancer and reference measurements from three board-certified radiologists.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
Tumor volume mean absolute error
5.2 cc
- EndpointTumor volume agreement with radiologist reference
- PopulationBreast MRI validation subset
- Tested versionTumorSight Viz submitted in K251766; build not stated
Segmentation volumetric Dice
0.76 Dice
- EndpointTumor segmentation overlap
- PopulationBreast MRI validation subset
- Tested versionTumorSight Viz submitted in K251766; build not stated
Segmentation surface Dice
0.92 Dice
- EndpointTumor segmentation surface overlap
- PopulationBreast MRI validation subset
- Tested versionTumorSight Viz submitted in K251766; build not stated
TumorSight Viz breast MRI measurement and segmentation validation
- DesignRetrospective multicenter validation against radiologist reference measurements
- Population267 samples from 266 patients with pathologically confirmed invasive early-stage or locally advanced breast cancer; MRI from GE, Philips, and Siemens 1.5T and 3T systems
- Scopeexact submission
- Tested versionTumorSight Viz submitted in K251766; build not stated
- Samplen=267
- IndependenceIndependence not established
K251766
Three board-certified radiologists established reference measurements; the FDA packet states more than eight U.S. sites.
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 or data-flow 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
24Fields 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) K251766: TumorSight Viz
Scope: identity, purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, deployment, evidenceSummary, evidenceMetrics, evidenceStudies
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
TumorSight Viz model card (K251766)
Scope: intendedUsers, careSetting, output, 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
-
TumorSight Viz official product page
Scope: productFamilyWorkflow, implementationCapabilities
Research history
-
K251766 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-authorized DEN170022
QuantX
Quantitative Insights, Inc
QuantX is breast MRI software for the labeled management, analysis, visualization, and decision-support workflow; exact image inputs, outputs, and use remain submission-specific.
- Modality
- MRI
- Anatomy
- Breast
- Decision
- 2017-07-19
FDA-cleared K243189
TumorSight Viz
SimBioSys, Inc.
Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable...
- Modality
- MRI
- Anatomy
- Breast, including biopsy-proven breast tumors/findings.
- Decision
- 2024-10-25
FDA-cleared K231130
TumorSight Viz
SimBioSys, Inc.
TumorSight Viz analyzes dynamic contrast-enhanced breast MRI for visualization and analysis of biopsy-proven early-stage or locally advanced breast cancer, including registration,...
- Modality
- MRI
- Anatomy
- Breast; early-stage or locally advanced breast cancer
- Decision
- 2023-12-26
FDA-cleared K253413
LiverMultiScan (v6.0)
Perspectum, Ltd.
LiverMultiScan v6.0 is MR diagnostic software for non-invasive liver-health assessment that generates, displays, and supports review of MR data and quantitative cT1, PDFF, and LIC...
- Modality
- MRI
- Anatomy
- Liver
- Decision
- 2026-03-09