CINA analyzes non-enhanced head CT and head CTA DICOM in parallel with standard interpretation to flag suspected intracranial hemorrhage and anterior-circulation large-vessel occlusion (distal ICA, MCA-M1 or proximal MCA-M2), issuing worklist and active notifications with informational previews for trained-radiologist triage; it does not diagnose or alter original images.
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
CINA analyzes non-enhanced head CT and head CTA DICOM in parallel with standard interpretation to flag suspected intracranial hemorrhage and anterior-circulation large-vessel occlusion (distal ICA, MCA-M1 or proximal MCA-M2), issuing worklist and active notifications with informational previews for trained-radiologist triage; it does not diagnose or alter original images.
Parallel worklist prioritization and notification for suspected ICH or anterior-circulation LVO; not a diagnostic device or replacement for standard interpretation.
Active pop-up and passive worklist notifications identifying the suspected finding type, plus a small compressed unannotated grayscale preview marked not for diagnostic use; original images are not altered.
LVO scope is limited to distal ICA, MCA-M1, or proximal MCA-M2 in the anterior circulation. Notifications and compressed previews are informational only, do not localize the finding, and require review of the full original images with other patient information.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The on-premise CINA Platform exchanges DICOM with CT modalities, routers, and PACS, runs the ICH and LVO applications, and transfers result files for worklist prioritization. Local routing, identifiers, failure handling, and workstation behavior require acceptance testing.
The reviewed exact packet does not establish the current scoped security controls, retention, access control, audit, vulnerability management, or incident-response package for K221716.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-08
The indication requires trained radiologists, but exact-version training and competency requirements were not established.
The exact submission describes DICOM exchange among CT, routers or PACS, an on-premise CINA Platform and Worklist Application, and result files returned for worklist prioritization.
Avicenna.AI's 2025 AVI announcement describes automated PACS/RIS integration, centralized orchestration, and DICOM, HL7, and FHIR support for the current platform hosting the CINA portfolio. It also describes de-identification, encryption, access controls, and auditable operations. These are family claims and do not establish the exact K221716 deployment or assurance scope.
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
K221716 contains two separately sized retrospective validation cohorts: 814 NCCT cases for ICH and 476 CTA cases for LVO. Results are reported per application and are not pooled.
DesignRetrospective blinded multicenter multinational standalone validation against concurrence of three US-board-certified neuroradiologists.
Population814 anonymized non-contrast head CT cases from three clinical sources (two US, one outside the US), including 255 ICH-positive cases and multiple scanner manufacturers.
Scopeexact submission
Tested versionCINA ICH/LVO triage configuration described in K221716
Samplen=814
Sites3
IndependenceSponsor or vendor study
K221716
Manufacturer-conducted FDA evidence; this is not an independent clinical-outcome study.
DesignRetrospective blinded multicenter multinational standalone validation against concurrence of three US-board-certified neuroradiologists.
Population476 anonymized head CTA cases from three clinical sources, including 188 anterior-circulation LVO-positive cases and multiple scanner manufacturers.
Scopeexact submission
Tested versionCINA ICH/LVO triage configuration described in K221716
Samplen=476
Sites3
IndependenceSponsor or vendor study
K221716
Manufacturer-conducted FDA evidence; this is not an independent clinical-outcome study.
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 2026-09-08
No public exact-version price, pricing unit, term, minimum, or implementation fee was established.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-08
No exact-product payer policy or claim eligibility was established.
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-submission FDA recall query returned no native recall record for K221716. This limited query does not establish absence of recalls or other safety information and does not cover family or later-version records.
Verify security and privacy controls: The reviewed exact packet does not establish the current scoped security controls, retention, access control, audit, vulnerability management, or incident-response package for K221716.
Verify training: The indication requires trained radiologists, but exact-version training and competency requirements were not established.
Verify pricing and total cost: No public exact-version price, pricing unit, term, minimum, or implementation fee was established.
Verify reimbursement and coding relevance: No exact-product payer policy or claim eligibility was established.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-08Last searched
26Fields reviewed
11Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
Stored exact-name candidate metadata was screened. The returned PubMed and trial records were unrelated to the CINA radiology product, so none was promoted; this is metadata triage, not a systematic literature review. 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, vendor press release, fda device recall, literature index, trial registry, stored candidate metadata, 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 history8 sources - 2 history items
Methinks CTA Stroke analyzes acute-setting brain CT angiography in adults over 21 with suspected stroke for suspected large-vessel occlusion in the terminal ICA, MCA-M1, or MCA-M2...
Rapid CTA 360 analyzes adult head CTA DICOM images to flag suspected large- and medium-vessel occlusion in specified intracranial and vertebral segments and notify trained...
Methinks NCCT Stroke analyzes adult non-contrast head CT to flag suspected intracranial hemorrhage and suspected large-vessel occlusion of the ICA, MCA-M1, or MCA-M2 for parallel...