trophon2— 510(k) K250434

Substantially Equivalent

Nanosonics

FDA 510(k) clearance K250434 for trophon2, Substantially Equivalent on 2025-08-05. Applicant: Nanosonics.

Clearance details

Applicant: Nanosonics
Product code: Code OUJ
Advisory panel: Radiology
Date received: 2025-02-14
Decision date: 2025-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Macquarie Park, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUJ

product code OUJ

Other: 1
Total: 1

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.