ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for TumorSight Viz; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-08FDA-cleared profile
TumorSight Viz
SimBioSys, Inc.
Authorized purpose: Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable finding visualization; results are not a 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: Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable finding visualization; results are not a sole basis for patient management.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable finding visualization; results are not a sole basis for patient management.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Breast, including biopsy-proven breast tumors/findings. Input: DICOM dynamic contrast-enhanced breast MRI studies acquired during contrast administration from patients with biopsy-proven early-stage or locally advanced breast cancer.
- Who uses it? Intended users: Skilled or qualified physicians interpreting and reviewing breast MRI analysis.
- What does the software produce? Output: Standard image views, MIPs, reformats, registrations, subtraction series, kinetic curves, parametric maps, segmentation and 3D volume renderings, automated linear and volume measurements, finding visualization, and DICOM import/retrieval/storage through the web application.
- What is its most important limitation? Key limitation: Patient management decisions must not be made solely from the results. The labeled context is contrast-enhanced breast MRI for biopsy-proven early-stage or locally advanced breast cancer; clinician review is required before use in planning.
Clinical takeaway
Clinical role: Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable finding visualization; results are not a sole basis for patient management.
Evidence takeaway
Evidence from the reviewed source record: FDA K243189 describes training/tuning data from 833 patients (916 samples) and an independent validation set from 216 patients (217 samples) at more than seven U.S. clinical sites; all patients had pathologically confirmed invasive early-stage or locally advanced breast cancer. Three board-certified radiologists established validation ground truth. Validation measurement mean absolute errors included tumor volume 5.22 +/- 15.58 cc, longest dimension 1.60 +/- 1.93 cm, tumor-to-nipple distance 1.20 +/- 1.37 cm, tumor-to-skin distance 0.63 +/- 0.61 cm, and tumor-to-chest distance 0.91 +/- 1.14 cm. Tumor segmentation volumetric Dice was 0.75 +/- 0.24 and surface Dice 0.88 +/- 0.24. A separate 197-case predicate comparison was also reported.
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
- Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable finding visualization; results are not a sole basis for patient management.
- Intended users
- Skilled or qualified physicians interpreting and reviewing breast MRI analysis.
- Care setting and population
- Breast MRI oncology and post-processing workflow for biopsy-proven early-stage or locally advanced breast cancer; facility type is not specified.
- Workflow role
- Breast MRI visualization, post-processing, segmentation, and measurement aid for clinician review and management or planning decisions.
- Required input
- DICOM dynamic contrast-enhanced breast MRI studies acquired during contrast administration from patients with biopsy-proven early-stage or locally advanced breast cancer.
- Output and human action
- Standard image views, MIPs, reformats, registrations, subtraction series, kinetic curves, parametric maps, segmentation and 3D volume renderings, automated linear and volume measurements, finding visualization, and DICOM import/retrieval/storage through the web application.
- Limitations
- Patient management decisions must not be made solely from the results. The labeled context is contrast-enhanced breast MRI for biopsy-proven early-stage or locally advanced breast cancer; clinician review is required before use in planning.
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
- Cloud-hosted software accessed through the TumorSight web application on an internet-connected computer; DICOM import, retrieval, study storage, and automated image import are described. A specific PACS/RIS/EHR interface is not established.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
- FDA K243189 describes training/tuning data from 833 patients (916 samples) and an independent validation set from 216 patients (217 samples) at more than seven U.S. clinical sites; all patients had pathologically confirmed invasive early-stage or locally advanced breast cancer. Three board-certified radiologists established validation ground truth. Validation measurement mean absolute errors included tumor volume 5.22 +/- 15.58 cc, longest dimension 1.60 +/- 1.93 cm, tumor-to-nipple distance 1.20 +/- 1.37 cm, tumor-to-skin distance 0.63 +/- 0.61 cm, and tumor-to-chest distance 0.91 +/- 1.14 cm. Tumor segmentation volumetric Dice was 0.75 +/- 0.24 and surface Dice 0.88 +/- 0.24. A separate 197-case predicate comparison was also reported.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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.
TumorSight Viz regulatory performance study summary
- DesignStand-Alone Performance
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K243189
- Samplen=833
- Sites9
- IndependenceIndependence not established
K243189
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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 price or quote for the exact K243189 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K243189. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K243189 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
21Fields 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
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FDA K243189: TumorSight Viz
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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TumorSight Viz model card (K243189)
Scope: intendedUsers, output, evidenceSummary, anatomy, evidenceStudies
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
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openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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openFDA exact recall query for K243189
Scope: postmarketSafety
Research history
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K243189 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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