# K133106: Computed Radiography Scanner

- Pathway: 510(k) (Special)
- Applicant: 3Disc Americas
- Decided: Jan 15, 2014 after 107 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: 4 generations back to K904519 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102619: Computed Raddiography Scanner, 3Disc Americas (2011) Summary page 1.

## Indications for use
This device isa Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP3) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image indigital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated ina radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data.

Source page: https://510kreport.com/device/K133106
Methodology: https://510kreport.com/methodology