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

Name: FDA 510(k) clearance K212321
Creator: U.S. Food and Drug Administration
Published: 2021-09-23

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. Device class: 2.

Clearance details

Applicant: Visus Health IT GmbH
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
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 ↗

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K231041 — JiveX (Model Number / Release: 5.4)2023-07-14
K200703 — JiveX2020-04-14
K181964 — JiveX2018-10-23

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.