Cleared Traditional

K013893 - SCANX
(FDA 510(k) Clearance)

K013893 · Air Techniques, Inc. · Radiology

Feb 2002

Decision

70d

Days

Class 2

Risk

K013893 is an FDA 510(k) clearance for the SCANX. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH).

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on February 1, 2002, 70 days after receiving the submission on November 23, 2001.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K013893 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2001
Decision Date	February 01, 2002
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement