Lumify Diagnostic Ultrasound System

Evidence summary

FDA review includes a retrospective FAST labeling evaluation of 82 emergency-department patients and 229 loops, plus a separate 20-patient clinical bench evaluation. These are anatomical-labeling studies, not evidence of improved trauma outcomes.

FDA source Exact FDA submission Checked 2026-09-05

• Source

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 security and privacy controls: No scoped, dated security attestation for the proposed mobile-device and PACS configuration was reviewed.
• Verify training: Required local onboarding, competency assessment and FAST-specific training package were not established.
• Verify pricing and total cost: A regional Philips subscription page did not establish current US pricing or inclusion of this FAST feature, hardware and support.
• Verify reimbursement and coding relevance: No applicable current payer policy was reviewed. An older vendor ultrasound coding guide is not current CMS coverage evidence for FAST Auto Assist.
• Verify local validation and lifecycle monitoring: Site-level label-error monitoring, update controls and support commitments remain to be confirmed.
• 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.

NCT03486444 concerns next-generation ultrasound education and care; stored metadata screened, but exact FAST Auto Assist/version linkage was not established. Live registry page returned a JavaScript shell; no trial results 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, vendor product page, literature index, clinical trial registry, recall database, pubmed, clinical trials, openfda device recall

• K252558 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
• 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
• Lumify Diagnostic Ultrasound System: K252558 decision and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• Lumify app Philips · 2026-09-05