Cleerly LABS (v2.0)

Evidence summary

Software verification and production-release regression testing support the submission changes; no new clinical cohort was reported.

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: Confirm the intended care setting, patient population, and service line.
• Verify security and privacy controls: A secured-network description is not a scoped security attestation.
• Verify training.
• Verify pricing and total cost: No public quote was located in reviewed material.
• Verify reimbursement and coding relevance: No applicable payer policy was reviewed.
• Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
• 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.

Stored trial metadata is a randomized personalized plaque-management study sponsored by Cleerly; it does not identify Cleerly LABS v2.0 and was retained only as an unreviewed family lead, not promoted. The current discovery snapshot contains 0 PubMed and 1 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 instructions for use, literature index, trial registry, pubmed, clinical trials, openfda device recall

• K242338 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Cleerly LABS (v2.0) model card (K242338) 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
• Cleerly LABS v2.0: K242338 clearance and 510(k) summary US Food and Drug Administration · 2026-09-05
• Cleerly manual upload instructions Cleerly · 2026-09-05