Cleared Traditional

K043104 - KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0

K043104 is an FDA 510(k) clearance for KODAK ORTHODONTIC IMAGING AND OMS IMAGI..., manufactured by Practiceworks, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K043104 · Practiceworks, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
107d
Days
Class 2
Risk

K043104 is an FDA 510(k) clearance for the KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Practiceworks, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 24, 2005 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K043104

510(k) Number K043104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2004
Decision Date February 24, 2005
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 Peers - EHD Unit, X-ray, Extraoral With Timer

All 187
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K043104 · KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
Download PDF FDA Summary Practiceworks, Inc.