JiveX (Model Number / Release: 5.3)— 510(k) K212321

Substantially Equivalent

Visus Health IT GmbH

FDA 510(k) clearance K212321 for JiveX (Model Number / Release: 5.3), Substantially Equivalent on 2021-09-23. Applicant: Visus Health IT GmbH.

Clearance details

Applicant: Visus Health IT GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-07-26
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bochum, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.