Radiology AI Directory

FDA-cleared profile

SIS System

Surgical Information Sciences, Inc.

Authorized purpose: SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.

Quantification 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: SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.

Evidence takeaway

Evidence from the reviewed source record: K230977 reports manufacturer software, registration, localization, and lead-segmentation validation.

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
SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Medical professionals, including but not limited to surgeons, neurologists and radiologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication names these medical-professional roles and does not establish the broader qualified and trained staff list in the dossier.

Care setting and population
Hospital neuroimaging, stroke, or neurosurgical planning workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Brain-image registration, segmentation, quantification, visualization, or procedure-planning support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
The patient's own clinical MR image and postoperative CT images in which implanted leads are visible.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description specifies clinical MR input and postoperative CT images for visible implanted leads; it does not establish associated clinical workflow data.

Output and human action
A patient-specific 3D anatomical model of specific brain structures, with implanted leads located and identified in relation to the brain structure of interest.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet supports the 3D model and lead localization/identification, not the dossier's broader list of measurements, maps, alerts and planning visualizations.

Limitations
The device can be used in conjunction with other clinical methods as an aid, and its output supplements the information available through standard clinical methods with additional, adjunctive information.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This is the exact adjunctive-use boundary in the indication and technological characteristics; the packet does not state the dossier's additional review, protocol, lesion or longitudinal-comparison wording.

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
K230977
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description identifies a patient's clinical MR image and postoperative CT images; it does not support the dossier's modality-unspecified wording. Controlled directory display reconciled from exact FDA wording: Clinical MR and postoperative CT imaging. -> Radiological images; modality varies or is not specified in FDA list.

Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-05-02
  • 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
DICOM import and output to PACS, workstations, or surgical systems; validate series selection, orientation, registration, measurements, routing, latency, and failure handling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Software workstation, server, virtual appliance, or connected clinical application using the cleared release.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

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 radiologists, neurologists, neurosurgeons, and trained imaging or surgical staff. 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 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model 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: Outputs are adjunctive and require review against source images and clinical context; modality, protocol, registration, lesion, anatomy, and longitudinal-comparison limits apply.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K230977 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM import and output to PACS, workstations, or surgical systems; validate series selection, orientation, registration, measurements, routing, latency, and failure handling.

exact submission · checked 2026-09-03

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. Outputs are adjunctive and require review against source images and clinical context; modality, protocol, registration, lesion, anatomy, and longitudinal-comparison limits apply.

exact submission · checked 2026-09-03

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 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model 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: Outputs are adjunctive and require review against source images and clinical context; modality, protocol, registration, lesion, anatomy, and longitudinal-comparison limits apply.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

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
K230977 reports manufacturer software, registration, localization, and lead-segmentation validation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K230977 FDA performance package for SIS System

  • DesignManufacturer software and image-processing validation
  • PopulationDBS planning and postoperative review using brain MRI and CT
  • Scopeexact submission
  • Tested versionSIS System release cleared in K230977
  • IndependenceSponsor or vendor study

K230977

Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

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 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, 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, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

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 K230977 by exact submission identifier. This does not exclude product-family or later safety information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields reviewed
11Source classes checked
10Screened PubMed leads
5Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 10 PubMed and 5 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 10 PubMed and 5 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, reimbursement policy, fda device recall, fda decision summary packet, 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 K230977: SIS System

    U.S. Food and Drug Administration - Published 2023-05-02 - Accessed 2026-09-19

    Scope: purpose, anatomy, evidenceSummary, modality, intendedUsers, input, output, limitations, clinicalUse

  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. K230977 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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SIS System

Surgical Information Sciences, Inc.

SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, GPi, and Vim, and segment implanted leads for surgical review.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2024-06-14
Quantification and segmentation