# K101289: Scanx D5000 Series Scanner Model: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB

- Pathway: 510(k) (Traditional)
- Applicant: Air Techniques, Inc.
- Decided: Aug 3, 2010 after 88 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 K013893 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K013893: SCANX, Air Techniques, Inc. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K081898: Expedium Spine System, Depuy Spine, Inc. (2008). Our OCR of the scanned summary read K081898, FDA’s number for Expedium Spine System (Depuy Spine, Inc.), which shares no word with the summary’s name for the device, “Portable X-Ray System “Any Ray””, apart from generic ones like “system”. Kept off the family tree. Summary page 2.

## Indications for use
The ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of x-ray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer’s memory. It will be used by physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose. These scanners are not intended to be used for mammographic images.

Source page: https://510kreport.com/device/K101289
Methodology: https://510kreport.com/methodology