SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

Evidence summary

The exact FDA 510(k) decision material establishes the submission identity, labeled use, inputs, population, and configuration boundary summarized here. No product-wide clinical-performance or outcome claim is promoted without an exact endpoint and version linkage.

FDA source Exact FDA submission Checked 2026-09-04

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

The 2026-09-02 openFDA device-recall snapshot contained no record matched to K250650 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.

Public source Exact FDA submission Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

• Source

• Verify deployment and data flow: The exact FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
• Verify security and privacy controls: 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.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
• Verify local validation and lifecycle monitoring: The exact FDA decision and checked recall snapshot do not establish a complete local postmarket monitoring protocol. Track version, population, anatomy, protocol, input quality, edits, failures, repeats, downstream effects, downtime, incidents, recalls, and updates locally.

Twenty PubMed records and ten trial records were screened. The results are generic spotlight-term collisions or unrelated studies and do not identify the Arineta SpotLight/Duo K250650 release. No evidence was promoted, and all 30 candidates remain 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, literature index, trial registry, pubmed, clinical trials, openfda device recall

• FDA 510(k) decision material K250650: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option U.S. Food and Drug Administration · 2026-09-04
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02