FDA-cleared profile
iSchema View Inc.
Authorized purpose: Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained professionals.
Product overview
Authorized purpose: Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained professionals.
Overview status: Source-reviewed overview
Clinical role: Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained professionals.
Evidence from the reviewed source record: K213165 reports software, algorithm, quantitative, interoperability, and workflow validation across the supported CT and MRI stroke-processing functions.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact packet uses this general user class and does not establish the current radiologist, neurologist, neurosurgeon, or surgical-staff list.
This replaces the unsupported brain and clinical-workflow additions with the packet's direct acquisition statement.
The replacement retains the packet's viewing, analysis, maps, and calculated perfusion outputs without adding unsupported alerts or planning visualizations.
The replacement uses the packet's direct physician-assessed thrombectomy boundary and listed contraindications/exclusions.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
The exact packet explicitly identifies the supported CT, CTP, CTA, and MRI datasets and modules. Controlled directory display reconciled from exact FDA wording: CT, CT Perfusion (CTP), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module. -> Radiological images; modality varies or is not specified in FDA list.
The packet names these vascular structures for the acute-stroke selection indication but does not state a general brain anatomy claim. Controlled directory display reconciled from exact FDA wording: intracranial internal carotid artery or proximal middle cerebral artery -> Brain.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
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.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K213165 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
DICOM import and output to PACS, workstations, or surgical systems; validate series selection, orientation, registration, measurements, routing, latency, and failure handling.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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. Each module has distinct inputs, timing, and intended-use limits. Outputs support trained professionals and do not replace source-image review or treatment eligibility assessment.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
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: Each module has distinct inputs, timing, and intended-use limits. Outputs support trained professionals and do not replace source-image review or treatment eligibility assessment.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
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.
Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
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.
K213165
Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 20 PubMed and 10 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 20 PubMed and 10 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 decision material, vendor product page, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: integration, deployment, monitoring, productFamilyContext
Scope: integration, deployment, monitoring, productFamilyContext
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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