IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0— 510(k) K022940

Name: FDA 510(k) clearance K022940
Creator: U.S. Food and Drug Administration
Published: 2002-10-11

Substantially Equivalent

Intelligent Images Srl

FDA 510(k) clearance K022940 for IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0, Substantially Equivalent on 2002-10-11. Applicant: Intelligent Images Srl. Device class: 2.

Clearance details

Applicant: Intelligent Images Srl
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2002-09-04
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Genova, Genova, IT

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K041581 — COMPACS, VERSION 1.02004-06-22

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.