DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I— 510(k) K040443

Name: FDA 510(k) clearance K040443
Creator: U.S. Food and Drug Administration
Published: 2004-06-16

Substantially Equivalent

Dome Imaging Systems, Inc.

FDA 510(k) clearance K040443 for DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I, Substantially Equivalent on 2004-06-16. Applicant: Dome Imaging Systems, Inc.. Device class: 2.

Clearance details

Applicant: Dome Imaging Systems, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2004-02-20
Decision date: 2004-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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K983815 — PACSCACHE1999-01-14

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 →

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