Cleared Traditional

K024285 - A/T X-RAY 70

K024285 is an FDA 510(k) clearance for A/T X-RAY 70, manufactured by Air Techniques, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K024285 · Air Techniques, Inc. · Radiology device
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Apr 2003
Decision
114d
Days
Class 2
Risk

K024285 is an FDA 510(k) clearance for the A/T X-RAY 70. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on April 16, 2003 after a review of 114 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.

View all Air Techniques, Inc. devices

FDA 510(k) Submission Details - K024285

510(k) Number K024285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date April 16, 2003
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
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 131
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K024285.
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
K040556 · Eastman Kodak Company · Apr 2004
TROPHYPAN AND TROPHYPAN C
K033690 · Trophy Radiologie · Feb 2004
ORTHOPHOS XG DS/CEPH
K033073 · Sirona Dental Systems GmbH · Oct 2003
MODIFICATION TO FOCUS
K022630 · Instrumentarium Corp. · Oct 2002
VERAVIEWEPOCS, MODEL VE
K013955 · J. Morita USA, Inc. · Feb 2002
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · Planmeca Oy · Jun 2001