Cleared Special

K042397 - SCANX 14

K042397 is the FDA 510(k) clearance for SCANX 14 by Air Techniques, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 33-day FDA review.

K042397 · Air Techniques, Inc. · Radiology device
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Oct 2004
Decision
33d
Days
Class 2
Risk

K042397 is an FDA 510(k) clearance for the SCANX 14. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on October 5, 2004 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Air Techniques, Inc. devices

Submission Details

510(k) Number K042397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 219
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K042397.
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K042602 · Ge Medical Systems, LLC · Jan 2005
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K042023 · Fujifilm Medical System U.S.A., Inc. · Aug 2004
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · Fujifilm Medical System U.S.A., Inc. · Nov 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633 · Canon USA, Inc. · Jun 2003