NovaGuide 2 Intelligent Ultrasound— 510(k) K213279

Substantially Equivalent

Novasignal Corporation

FDA 510(k) clearance K213279 for NovaGuide 2 Intelligent Ultrasound, Substantially Equivalent on 2022-03-02. Applicant: Novasignal Corporation.

Clearance details

Applicant: Novasignal Corporation
Product code: Code IYN
Advisory panel: Radiology
Date received: 2021-10-01
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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.