LARALAB

Evidence summary

Multicenter standalone observational evaluation of 60 CT cases, divided equally across aortic, mitral and tricuspid planning; expert manual measurements using 3mensio served as comparator. Patients were aged 62-97; 45% were male.

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 security and privacy controls: FDA-described access/encryption controls are not a current scoped security certification. Hosting region, retention, contractual data controls and dated attestations were not established.
• Verify training: User qualification requirements beyond intended-user categories and the contracted onboarding package remain to be confirmed.
• Verify pricing and total cost: Reviewed vendor pages did not establish a dated exact-version license or planning-case rate.
• Verify reimbursement and coding relevance: No applicable payer policy for this planning software was reviewed.
• Verify local validation and lifecycle monitoring: Site acceptance should address segmentation corrections and report transfer; this is editorial guidance, not a verified monitoring capability.
• 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.

PMID40155128 identifies the family planning tool in a single case and is retained contextually. NCT06951126 stored metadata concerns CT prediction for transcatheter tricuspid interventions; exact product/version applicability remains unestablished. Registry page returned a JavaScript shell; no trial outcomes promoted. The current discovery snapshot contains 1 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 product page, literature index, peer reviewed publication, trial registry, recall database, pubmed, clinical trials, openfda device recall

• K242500 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
• LARALAB GmbH model card (K242500) 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
• LARALAB: K242500 decision and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• LARALAB heart.ai LARALAB · 2026-09-05
• Staged transcatheter mitral and tricuspid valve replacement case report JACC Case Reports / PubMed · 2026-09-05