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 shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
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.
FDA source Exact FDA submission Checked 2026-09-08
Parallel worklist prioritization and notification for suspected ICH or anterior-circulation LVO; not a diagnostic device or replacement for standard interpretation.
FDA source Exact FDA submission Checked 2026-09-08
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.
FDA source Exact FDA submission Checked 2026-09-08
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.
FDA source Exact FDA submission Checked 2026-09-08
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
K221716
FDA source Exact FDA submission Checked 2026-08-31
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.
FDA source Exact FDA submission Checked 2026-09-08
Vendor confirmation Exact FDA submission Checked 2026-09-08
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.
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.
FDA source Exact FDA submission Checked 2026-09-08
Suspected ICH triage sensitivity against concurrence of three US-board-certified neuroradiologists in 814 anonymized non-contrast head CT cases; 255 ICH-positive.
Tested version: CINA ICH/LVO triage configuration described in K221716
Anterior-circulation LVO triage sensitivity against concurrence of three US-board-certified neuroradiologists in 476 anonymized head CTA cases; 188 LVO-positive.
Tested version: CINA ICH/LVO triage configuration described in K221716
Retrospective blinded multicenter multinational standalone validation against concurrence of three US-board-certified neuroradiologists. · 814 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.
exact submission · Tested version: CINA ICH/LVO triage configuration described in K221716 · n=814 · 3 sites · Sponsor or vendor study
K221716
Manufacturer-conducted FDA evidence; this is not an independent clinical-outcome study.
Retrospective blinded multicenter multinational standalone validation against concurrence of three US-board-certified neuroradiologists. · 476 anonymized head CTA cases from three clinical sources, including 188 anterior-circulation LVO-positive cases and multiple scanner manufacturers.
exact submission · Tested version: CINA ICH/LVO triage configuration described in K221716 · n=476 · 3 sites · Sponsor 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.
Public source Exact FDA submission Checked 2026-09-08
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
20Reviewed PubMed leads
10Reviewed 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
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...