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

Name: FDA 510(k) clearance K190314
Creator: U.S. Food and Drug Administration
Published: 2019-10-09

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.. Device class: 2.

Clearance details

Applicant: Mednovel Technology, Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2019-02-13
Decision date: 2019-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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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.