# K133120: 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 is a 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 (IP)and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified stiff. This device is not intended for the acquisition of mammagraphic image data.

Source page: https://510kreport.com/device/K133120
Methodology: https://510kreport.com/methodology