Cleared Traditional

SCANX 10

K031198 · Air Techniques, Inc. · Radiology
Jun 2003
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K031198 is an FDA 510(k) clearance for the SCANX 10, 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 June 20, 2003, 65 days after receiving the submission on April 16, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K031198 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2003
Decision Date June 20, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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