FDA-cleared profile
MaxQ-Al Ltd.
Accipiolx prioritizes adult noncontrast head CT studies for cases with acute intracranial hemorrhage by sending studies from PACS to an analysis engine and returning case-level worklist priority; it is not a standalone diagnostic or rule-out system.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
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.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
This is the interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
This is the release-level boundary described in the exact FDA package; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence.
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.
Monitoring guidance is buyer-facing implementation guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K182177 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The FDA package describes installation in a healthcare radiology network; current hosting, service, security, availability, and upgrade boundaries remain unverified.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA package describes transfer of adult noncontrast head CT from PACS to an analysis engine and return of case-level priority to the worklist.
exact submission · checked 2026-09-04Test 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. Accipiolx prioritizes eligible adult noncontrast head CT cases but is not a standalone diagnosis, rule-out, or replacement for complete physician review.
exact submission · checked 2026-09-04Define 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 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K182177 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: Accipiolx prioritizes eligible adult noncontrast head CT cases but is not a standalone diagnosis, rule-out, or replacement for complete physician review.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. acute intracranial-hemorrhage triage software limits remain submission-specific.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
Case-level triage sensitivity in 360 adult noncontrast head CT cases from more than 30 U.S. sites.
Tested version: Accipiolx configuration described in K182177Case-level triage specificity in 360 adult noncontrast head CT cases from more than 30 U.S. sites.
Tested version: Accipiolx configuration described in K182177Mean time to process a case in 360 adult noncontrast head CT cases from more than 30 U.S. sites.
Tested version: Accipiolx configuration described in K182177FDA 510(k) retrospective performance study using adult noncontrast head CT cases and neuroradiologist consensus reference labels. · 360 adult noncontrast head CT cases from more than 30 U.S. sites evaluated for acute intracranial hemorrhage triage.
exact submission · Tested version: Accipiolx configuration described in K182177 · n=360 · Sponsor or vendor studyK182177
The FDA package reports sensitivity, specificity, and average processing time for the exact Accipiolx study.
Economics and lifecycle
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, 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 StatesThis is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.
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.
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K182177; review status is candidate_review_pending. Literature and registry candidates remain quarantined unless exact submission and tested-version linkage is established. The checked recall disposition is no exact-submission recall record was promoted; ambiguous or family-only candidates are not published. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 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, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
Alternatives
JLK, Inc.
Notification-only triage of suspected intracranial hemorrhage on non-contrast head CT
Aidoc Medical, Ltd.
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AVICENNA.AI
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