Cleared Traditional

K944162 - DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM

K944162 is an FDA 510(k) clearance for DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM, manufactured by Teledyne Water Pik. The device is a Class 2 Radiology device with product code EAG cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K944162 · Teledyne Water Pik · Radiology device
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Nov 1994
Decision
95d
Days
Class 2
Risk

K944162 is an FDA 510(k) clearance for the DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM. Classified as Cephalometer (product code EAG), Class II - Special Controls.

Submitted by Teledyne Water Pik (Fort Collins, US). The FDA issued a Cleared decision on November 29, 1994 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1830 - 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.

View all Teledyne Water Pik devices

FDA 510(k) Submission Details - K944162

510(k) Number K944162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date November 29, 1994
Days to Decision 95 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 107d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAG Device Classification - Class 2, Special Controls

Product Code EAG Cephalometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1830
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.