Radiology AI Directory

FDA-cleared profile

Rapid ICH

iSchemaView Inc.

Assist hospital networks and trained radiologists with workflow triage by flagging and communicating suspected IPH, IVH, SAH, and SDH findings in non-enhanced head CT images.

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.

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
Assist hospital networks and trained radiologists with workflow triage by flagging and communicating suspected IPH, IVH, SAH, and SDH findings in non-enhanced head CT images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Hospital networks and trained radiologists; notified radiologists must review the full images under the standard of care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Hospital-network workflow triage in parallel with standard of care; the packet describes a server or standalone desktop application.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Triage and notification prioritization; the device does not alter the original image and provides a compressed preview for notification rather than diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Non-enhanced head CT/NCCT images processed through the Rapid Platform's DICOM services.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Priority notifications for cases with suspected IPH, IVH, SAH, or SDH; compressed preview images; and notification delivery through the described PACS, workstation, email, and mobile pathways.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Compressed previews are informational only and not for diagnosis beyond notification. Results must be used with other patient information and professional judgment; notified radiologists must view full images per standard of care. The device is not a diagnostic device and does not alter the original medical image.
  • 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
K221456
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Head/brain; suspected intraparenchymal, intraventricular, subarachnoid, and subdural intracranial hemorrhage.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-09-12
  • 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 Rapid Platform provides DICOM processing, job management, imaging execution, notifications, and compressed-image output; the packet lists PACS, workstation, email, and mobile notification pathways. It does not establish a universal local interface, hosting model, or PACS/RIS/EHR version compatibility.
  • 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

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Rapid ICH; 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
FDA K221456 reports a retrospective, blinded, multicenter, multinational study of 314 NCCT cases (148 ICH-positive and 166 ICH-negative). Overall sensitivity was 96.8% (95% CI 92.6%-98.6%) and specificity was 100% (95% CI 97.7%-100%), exceeding the 80% performance goal. AUC was 0.98632, and time-to-notification was 0.65 minutes (95% CI 0.63-0.67) versus standard-of-care time-to-exam-open 72.58 minutes (95% CI 45.02-100.14); these are distinct endpoints. Subgroup results were reported by age, gender, hemorrhage subtype, volume, slice thickness, scanner manufacturer, make/model, and reconstruction method.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Overall Rapid ICH sensitivity: 96.8% (95% CI 92.6%-98.6%) in the FDA retrospective blinded multicenter/multinational study of 314 NCCT cases, with 148 ICH-positive and 166 ICH-negative cases.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The 80% figure is the prespecified performance goal, not the observed sensitivity; AUC, subtype results, and time-to-notification are separate endpoints.

Reported specificity
Overall Rapid ICH specificity: 100% (95% CI 97.7%-100%) in the same 314-case NCCT study.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

This preserves the overall specificity endpoint and prevents the active-row 98.6% sensitivity confidence bound or 80% goal from being presented as specificity.

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

RapidICH 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 K221456
  • Samplen=314
  • IndependenceIndependence not established

K221456

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 K221456 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 K221456. 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
2026-09-09Last searched
24Fields reviewed
9Source classes checked
4Awaiting review PubMed leads
1Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 4 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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 K221456: Rapid ICH

    U.S. Food and Drug Administration - Published 2022-09-12 - 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. RapidICH model card (K221456)

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

    Scope: intendedUsers, output, limitations, 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 K221456

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

    Scope: postmarketSafety

Research history

  1. K221456 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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