# K042397: SCANX 14

- Pathway: 510(k) (Special)
- Applicant: Air Techniques, Inc.
- Decided: Oct 5, 2004 after 33 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031198 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031198: SCANX 10, Air Techniques, Inc. (2003) Summary page 3.

## Indications for use
The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by physicians and authorized medical auxiliary personnel for this purpose. This is the same intended use as previously cleared for the ScanX 12 (Formerly ScanX 10), 510(k) number K031198.

Source page: https://510kreport.com/device/K042397
Methodology: https://510kreport.com/methodology
