Cleared Special

K042397 - SCANX 14
(FDA 510(k) Clearance)

K042397 · Air Techniques, Inc. · Radiology

Oct 2004

Decision

33d

Days

Class 2

Risk

K042397 is an FDA 510(k) clearance for the SCANX 14, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on October 5, 2004, 33 days after receiving the submission on September 2, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K042397 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2004
Decision Date	October 05, 2004
Days to Decision	33 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Statement