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 ยท checked 2026-09-08FDA-cleared profile
Rapid ICH
iSchemaView Incorporated
Authorized purpose: Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage; results do not replace diagnostic interpretation.
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 of adult noncontrast head CT for suspected intracranial hemorrhage; results do not replace diagnostic interpretation.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage; results do not replace diagnostic interpretation.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain Input: Non-enhanced head CT images
- Who uses it? Intended users: hospital networks and trained radiologists
- What does the software produce? Output: Notifications for cases with suspected ICH findings, including compressed preview images meant for informational purposes only and not intended for diagnostic use beyond notification.
- What is its most important limitation? Key limitation: Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation before making care-related decisions or requests.
Clinical takeaway
Clinical role: Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage; results do not replace diagnostic interpretation.
Evidence takeaway
Evidence from the reviewed source record: iSchemaView conducted a retrospective, blinded, multicenter, multinational study with RAPID ICH to evaluate performance in identifying noncontrast CT head images containing ICH findings in 336 cases. Sensitivity was 0.899, specificity was 0.943, and time to notification of suspicion/non-suspicion was 2.28 minutes.
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 of adult noncontrast head CT for suspected intracranial hemorrhage; results do not replace diagnostic interpretation.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
- Intended users
- hospital networks and trained radiologists
The exact indication names hospital networks and trained radiologists as the intended workflow users.
- Care setting and population
- Adult patients; the institutional care setting requires local confirmation.
Conservative normalization of explicit wording in an exact-submission source.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Non-enhanced head CT images
The exact indication states analysis of non-enhanced head CT images; the current CT/CTA input wording is broader than the RAPID ICH indication.
- Output and human action
- Notifications for cases with suspected ICH findings, including compressed preview images meant for informational purposes only and not intended for diagnostic use beyond notification.
The exact module description and indication define notification and compressed-preview output and its informational-only boundary.
- Limitations
- Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation before making care-related decisions or requests.
The exact cautions state the preview, non-diagnostic, unchanged-image, full-image-review, and patient-evaluation boundaries.
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
- K193087
- Modality
- CT/CTA
The exact RAPID ICH indication and performance description specify non-enhanced/noncontrast head CT rather than the broader CT/CTA value. Controlled directory display reconciled from exact FDA wording: Non-enhanced head CT -> CT/CTA.
- Anatomy
- Brain
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2020-03-31
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premise
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
- iSchemaView conducted a retrospective, blinded, multicenter, multinational study with RAPID ICH to evaluate performance in identifying noncontrast CT head images containing ICH findings in 336 cases. Sensitivity was 0.899, specificity was 0.943, and time to notification of suspicion/non-suspicion was 2.28 minutes.
The exact packet reports the 336-case study, exact sensitivity and specificity, and time-to-notification result; the prior 80% values are not retained.
- Reported sensitivity
- 80%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
- Reported specificity
- 80%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
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 K193087 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 K193087. 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 K193087 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
24Fields reviewed
10Source classes checked
4Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 4 PubMed and 1 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 4 PubMed and 1 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, fda decision summary packet, 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 K193087: Rapid ICH
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Rapid ICH model card (K193087)
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K193087
Scope: postmarketSafety
Research history
-
K193087 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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