Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory— 510(k) K202742

Substantially Equivalent

Viasonix , Ltd.

FDA 510(k) clearance K202742 for Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory, Substantially Equivalent on 2021-01-25. Applicant: Viasonix , Ltd..

Clearance details

Applicant: Viasonix , Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2020-09-18
Decision date: 2021-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.