Radiology AI Directory

FDA-cleared profile

Rapid (6.0)

iSchemaView, Inc.

Rapid Platform v6.0 is image-processing software for trained professionals that views, processes, and analyzes DICOM images from CT and MRI. It supports functional and dynamic datasets including CT perfusion, CT angiography, diffusion-weighted MRI, and dynamic contrast-enhanced CT or MRI, with maps and measurements for tissue perfusion, diffusion, and blood volume. Rapid CT-Perfusion and Rapid MR-Perfusion may aid physicians in selecting acute stroke patients with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery for endovascular thrombectomy, subject to the labeled imaging criteria, clinical requirements, and exclusions.

Stroke and ICH triageQuantification 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.

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
Rapid Platform v6.0 is image-processing software for trained professionals that views, processes, and analyzes DICOM images from CT and MRI. It supports functional and dynamic datasets including CT perfusion, CT angiography, diffusion-weighted MRI, and dynamic contrast-enhanced CT or MRI, with maps and measurements for tissue perfusion, diffusion, and blood volume. Rapid CT-Perfusion and Rapid MR-Perfusion may aid physicians in selecting acute stroke patients with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery for endovascular thrombectomy, subject to the labeled imaging criteria, clinical requirements, and exclusions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained physicians, radiologists, technologists, and other medical-image professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Clinical image-review and post-processing environments within the labeled workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Multimodality image viewing, processing, analysis, measurement, comparison, and reporting under professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported DICOM CT, MR, PET, SPECT, X-ray, ultrasound, or other labeled medical-image inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Multimodality images, fused views, quantitative results, contours, measurements, and reports for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The exact indication is limited to supported CT and MR datasets and labeled acute-stroke selection criteria; inadequate bolus, excessive motion, hemorrhage, clinical contraindications, and other listed exclusions require professional assessment. Rapid does not replace physician judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K233512
  • 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 2026-09-04
Anatomy
Brain and intracranial vessels represented in CT perfusion, CTA, and MRI; tissue perfusion, diffusion, and contrast dynamics
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-01-16
  • 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 exact FDA package describes DICOM input from files, media, network, CT or MR consoles, PACS, or workstations and DICOM result output to external consumers; verify patient identity, modality selection, routing, result delivery, archive, and downtime behavior.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is a partial interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.

Deployment and data flow
The exact FDA package describes standard Rapid on a customer Linux server, Virtual Rapid on VMware or another virtual platform, and online or hybrid configurations; current hosting, contracts, security, availability, and site configuration remain unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is a partial release-level topology fact from the exact FDA package; current hosting, contracts, security, availability, and site configuration remain separate evidence.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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 trained physicians, radiologists, technologists, and other medical-image professionals 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 2026-09-04
Monitoring and change control
Monitor K233512 by exact hardware, software, model, and algorithm 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: The exact indication is limited to supported CT and MR datasets and labeled acute-stroke selection criteria; inadequate bolus, excessive motion, hemorrhage, clinical contraindications, and other listed exclusions require professional assessment. Rapid does not replace physician judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K233512 before acceptance.

exact submission · checked 2026-09-04

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

Source

Deployment boundary

The exact FDA package describes standard Rapid on a customer Linux server, Virtual Rapid on VMware or another virtual platform, and online or hybrid configurations; current hosting, contracts, security, availability, and site configuration remain unknown.

exact submission · checked 2026-09-04

FDA-described topology does not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact FDA package describes DICOM input from files, media, network, CT or MR consoles, PACS, or workstations and DICOM result output to external consumers; verify patient identity, modality selection, routing, result delivery, archive, and downtime behavior.

exact submission · checked 2026-09-04

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. The exact indication is limited to supported CT and MR datasets and labeled acute-stroke selection criteria; inadequate bolus, excessive motion, hemorrhage, clinical contraindications, and other listed exclusions require professional assessment. Rapid does not replace physician judgment.

exact submission · checked 2026-09-04

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.

exact submission · checked 2026-09-04

No exact-product price or reimbursement determination was promoted.

Source

Lifecycle monitoring

Monitor K233512 by exact hardware, software, model, and algorithm 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: The exact indication is limited to supported CT and MR datasets and labeled acute-stroke selection criteria; inadequate bolus, excessive motion, hemorrhage, clinical contraindications, and other listed exclusions require professional assessment. Rapid does not replace physician judgment.

exact submission · checked 2026-09-04

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
K233512 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

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

K233512 FDA decision evidence package for Rapid (6.0)

  • DesignFDA decision evidence and product verification described in the exact submission or PMA decision record.
  • PopulationBrain and intracranial vessels represented in CT perfusion, CTA, and MRI; tissue perfusion, diffusion, and contrast dynamics
  • Scopeexact submission
  • Tested versionRapid (6.0) configuration described in K233512
  • IndependenceSponsor or vendor study

K233512

FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation unless the exact source expressly establishes that distinction; local technical, clinical, privacy, security, 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 2026-09-04

No public list price for the exact cleared or authorized configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product reimbursement determination was promoted in this timeboxed review. Verify payer, site-of-service, coding, coverage, and local payment assumptions independently.

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 K233512 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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
2026-09-04Last searched
26Fields reviewed
8Source classes checked
20Awaiting review PubMed leads
10Awaiting 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. Scope was limited to exact FDA decision material and exact-submission recall disposition already present in the checked snapshot. Optional literature, vendor, pricing, and deployment research was not promoted. Automated exact-name discovery found 20 PubMed and 10 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 decision material, fda device recall, 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 510(k) decision material K233512: Rapid (6.0)

    U.S. Food and Drug Administration - Published 2024-01-16 - Accessed 2026-09-04

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

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Rapid (6.0) model card (K233512)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, integration, anatomy, 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

Research history

  1. K233512 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K253969

ADAS 3D

Adas3D Medical S.L.

ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart; myocardial scar and cardiac structures
Decision
2026-06-29
Radiotherapy planningCardiac imagingOncology quantification
FDA-cleared K261713

Synapse PACS (7.6.0)

FUJIFILM Healthcare Americas Corporation

Synapse PACS 7.6.0 provides medical-image management and processing, including measurements, regional segmentation, clinical calculations, structured reports, comparison, fusion,...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2026-06-18
Quantification and segmentation
FDA-cleared K252563

Neurophet SCALE PET

Neurophet., Inc.

Brain MRI/PET registration, segmentation and quantitative PET assessment

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2026-05-15
Quantification and segmentation