Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000— 510(k) K190314

Substantially Equivalent

Mednovel Technology, Ltd.

FDA 510(k) clearance K190314 for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000, Substantially Equivalent on 2019-10-09. Applicant: Mednovel Technology, Ltd..

Clearance details

Applicant: Mednovel Technology, Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2019-02-13
Decision date: 2019-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.