TROPHON— 510(k) K103059

Substantially Equivalent

Nanosonics Limited

FDA 510(k) clearance K103059 for TROPHON, Substantially Equivalent on 2011-02-24. Applicant: Nanosonics Limited.

Clearance details

Applicant: Nanosonics Limited
Product code: Code OUJ
Advisory panel: Radiology
Date received: 2010-10-15
Decision date: 2011-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, Nsw, 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.