Radiology AI Directory

FDA-cleared profile

Hyper Insight - ICH

SK Inc.

Authorized purpose: Notification-only triage for suspected acute intracranial hemorrhage on non-contrast brain CT, sharing cases with medical specialists in parallel with standard care.

Stroke and ICH triageAcute triage and notification
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: Notification-only triage for suspected acute intracranial hemorrhage on non-contrast brain CT, sharing cases with medical specialists in parallel with standard care.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Notification-only triage for suspected acute intracranial hemorrhage on non-contrast brain CT, sharing cases with medical specialists in parallel with standard care.

Evidence takeaway

Evidence from the reviewed source record: FDA retrospective testing used 394 brain CT images from 13 U.S. clinical sites, including 198 ICH-positive and 196 ICH-negative images, with ground truth established by trained neuro-radiologists and a reference-standard committee. Subject sensitivity was 95.45% (95% CI 91.55%-97.90%), specificity was 98.47% (95% CI 95.59%-99.68%), AUC was 0.9864 (95% CI 0.9738-0.9989), and mean time to notification was 16.39 +/- 5.46 seconds. The pre-specified sensitivity and specificity performance goal was 80%.

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
Notification-only triage for suspected acute intracranial hemorrhage on non-contrast brain CT, sharing cases with medical specialists in parallel with standard care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists, emergency-medicine physicians, neurosurgeons, neurologists, and other trained clinicians or medical specialists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Clinical or hospital environment, including acute neuroimaging and emergency triage workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Parallel notification and worklist-prioritization tool; returns suspected ICH or case-processed status to a PACS/workstation and mobile preview workflow while the specialist performs full diagnostic interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM non-contrast head CT images. The FDA packet states a contraindication for analyzing otherwise eligible non-contrast CT scans acquired on scanners from manufacturers other than General Electric or its subsidiaries.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A binary suspected-ICH or case-processed result, no image marking, and a non-diagnostic preview or notification delivered through the worklist, PACS/workstation, or mobile application for specialist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Notification and preview are not diagnostic and cannot substitute for full patient assessment or diagnostic-viewer interpretation. The packet states a GE-scanner contraindication for otherwise eligible non-contrast CT and requires specialist review; exact current deployment, security, and interface versions are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K240353
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-07-01
  • 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
A third-party worklist application receives analysis requests and DICOM images and receives the ICH finding back for radiologist alerts; the comparison table identifies DICOM compatibility, PACS/workstation results, and mobile non-diagnostic preview.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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 2026-09-08

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 2026-09-08

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 2026-09-08

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

Result destination

PACS and workstation are explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Hyper Insight - ICH; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
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
FDA retrospective testing used 394 brain CT images from 13 U.S. clinical sites, including 198 ICH-positive and 196 ICH-negative images, with ground truth established by trained neuro-radiologists and a reference-standard committee. Subject sensitivity was 95.45% (95% CI 91.55%-97.90%), specificity was 98.47% (95% CI 95.59%-99.68%), AUC was 0.9864 (95% CI 0.9738-0.9989), and mean time to notification was 16.39 +/- 5.46 seconds. The pre-specified sensitivity and specificity performance goal was 80%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
95.45% (95% CI: 91.55%, 97.90%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
98.47% (95% CI: 95.59%, 99.68%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

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

Hyper Insight - ICH 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 K240353
  • Samplen=394
  • Sites13
  • IndependenceIndependence not established

K240353

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 2026-09-08

No public price or quote for the exact K240353 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K240353. 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 2026-09-08

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
24Fields 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 K240353: Hyper Insight - ICH

    U.S. Food and Drug Administration - Published 2024-07-01 - Accessed 2026-09-08

    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. Hyper Insight - ICH model card (K240353)

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

    Scope: intendedUsers, output, reportedSensitivity, reportedSpecificity, 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 K240353

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

    Scope: postmarketSafety

Research history

  1. K240353 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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