ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X— 510(k) K022824

Name: FDA 510(k) clearance K022824
Creator: U.S. Food and Drug Administration
Published: 2002-10-17

Substantially Equivalent

Tomtec Imaging Systems GmbH

FDA 510(k) clearance K022824 for ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X, Substantially Equivalent on 2002-10-17. Applicant: Tomtec Imaging Systems GmbH. Device class: 2.

Clearance details

Applicant: Tomtec Imaging Systems GmbH
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2002-08-26
Decision date: 2002-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Unterschleissheim, DE

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K132544 — TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA2013-11-25
K122289 — IMAGE-COM 5.02012-10-24

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.