Mosaic (V1.0.1)— 510(k) K244012

Substantially Equivalent

Navier Medical

FDA 510(k) clearance K244012 for Mosaic (V1.0.1), Substantially Equivalent on 2025-06-16. Applicant: Navier Medical.

Clearance details

Applicant: Navier Medical
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2024-12-26
Decision date: 2025-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.