ClariCT.AI

Evidence summary

The FDA summary describes nonclinical system, performance, phantom, and risk-based safety testing and states clinical studies were not required to demonstrate substantial equivalence.

FDA source Exact FDA submission Checked 2026-09-05

• Source

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

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify care setting and population: CT-to-PACS use is described, but exhaustive patient-age and care-setting eligibility were not established in the reviewed text.
• Verify security and privacy controls: No dated, scoped attestation was reviewed. PHI handling, image-cache retention, access control, audit, and incident-response terms remain unverified.
• Verify training: Current protocol/noise-setting training and support commitments were not established.
• Verify pricing and total cost: The product page gives no scoped price. Software, workstation/GPU, installation, support, and upgrade costs need quotation; procurement research is incomplete.
• Verify reimbursement and coding relevance: No applicable payer policy was reviewed. CT examination reimbursement does not establish separate software payment.
• Verify local validation and lifecycle monitoring: Dose/protocol-specific acceptance, original/processed image review, update control, and escalation require a site/vendor plan; these are editorial evaluation needs.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Both stored trial metadata records screened. NCT05804799 live registry supports a contextual family study without exact-version results. NCT05577884 concerns ultra-low-dose whole-body CT in multiple myeloma; its direct page returned a shell and protocol/version linkage was not established, so no result was promoted. No stored PubMed candidates. The current discovery snapshot contains 0 PubMed and 2 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, fda decision material, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) K183460: ClariCT.AI U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• ClariCT.AI model card (K183460) American College of Radiology · 2026-09-01
• 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
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• ClariCT.AI official product and integration page ClariPi Inc. · 2026-09-05
• NCT05804799: Liver CT Dose Reduction With Deep Learning Based Reconstruction ClinicalTrials.gov; record supplied by Seoul National University Hospital · 2026-09-05