Cleared Traditional

A/T X-RAY 70

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

About This 510(k) Submission

K024285 is an FDA 510(k) clearance for the A/T X-RAY 70, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on April 16, 2003, 114 days after receiving the submission on December 23, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K024285 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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