# K120131: Regius SIGMA2

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Feb 10, 2012 after 24 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: 5 generations back to K023061 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103703: Reguis Sigma, Konica Minolta Medical & Graphic, Inc. (2011) Summary page 1.

## Indications for use
The Direct Digitizer, REGIUS SIGMA2 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities. This device is not intended for use in mammography.

Source page: https://510kreport.com/device/K120131
Methodology: https://510kreport.com/methodology