Cleared Traditional

K040443 - DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I

K040443 is an FDA 510(k) clearance for DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, manufactured by Dome Imaging Systems, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K040443 · Dome Imaging Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
117d
Days
Class 2
Risk

K040443 is an FDA 510(k) clearance for the DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Dome Imaging Systems, Inc. (Waltham, US). The FDA issued a Cleared decision on June 16, 2004 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K040443

510(k) Number K040443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2004
Decision Date June 16, 2004
Days to Decision 117 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 107d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2293
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K040443 · DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I
Download PDF FDA Summary Dome Imaging Systems,…