trophon Wireless Ultrasound Probe Holder— 510(k) K241536

Name: FDA 510(k) clearance K241536
Creator: U.S. Food and Drug Administration
Published: 2024-09-27

Substantially Equivalent

Nanosonics Limited

FDA 510(k) clearance K241536 for trophon Wireless Ultrasound Probe Holder, Substantially Equivalent on 2024-09-27. Applicant: Nanosonics Limited. Device class: 2.

Clearance details

Applicant: Nanosonics Limited
Product code: Code OUJ
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2024-05-30
Decision date: 2024-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Macquarie Park, AU

Download summary PDF View on FDA.gov ↗

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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.