FDA-cleared profile
Arineta Ltd.
SpotLight and Duo produce cross-sectional images from X-ray transmission data for cardiovascular and thoracic examinations, including heart imaging with or without contrast and low-dose lung-cancer-screening protocols under established governmental or professional guidance.
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.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
The exact installed deployment, hosting, service, and operational boundary is not established by the reviewed public FDA material.
The FDA decision material does not establish the complete security posture for the exact product and deployment. Obtain architecture, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K241200 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, report, and downtime contract locally.
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 exact labeled population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use only the cleared populations, protocols, reconstructions, applications, and patient-size limits; local dose, image-quality, geometry, and downstream acceptance remain necessary.
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 reviewed public material; productivity or value claims require local evidence.
Monitor 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.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. No exact native-submission recall record was found in the checked snapshot; this does not exclude other product-family or later signals.
The exact installed deployment, hosting, service, security, and operational boundary remains unverified and requires site-specific confirmation.
exact submission · checked 2026-09-04FDA-described deployment details do not establish current hosting contracts, security controls, uptime, or local qualification.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
No single product-level sensitivity value was promoted because the reviewed FDA material is workflow, module, sequence, or population specific.
No single product-level specificity value was promoted because the reviewed FDA material is workflow, module, sequence, or population specific.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) decision evidence package reviewed for exact submission identity and labeled scope · Labeled population and configuration described in the K241200 FDA decision material
exact submission · Tested version: SpotLight and Duo configuration described in K241200 · Sponsor or vendor studyK241200
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
FDA 510(k) verification and validation evidence described in the exact submission · Cardiovascular, thoracic, and lung anatomy
exact submission · Tested version: SpotLight and SpotLight Duo configuration described in K241200 · Sponsor or vendor studyK241200
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
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 product version was established. Obtain a written quote separating license, implementation, interfaces, compute, storage, training, support, upgrades, renewal, 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.
No separate named-product payment identified in reviewed CMS material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. 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.
Screened 20 PubMed titles and 10 trial records. The records are lexical matches for spotlight, including an unrelated concussion app, and none identifies Arineta SpotLight or SpotLight Duo under K241200; all 30 are quarantined. 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, 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.
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