# K052095: Modification to: Direct Digitizer Regius Model 190

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Nov 3, 2005 after 101 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: 2 generations back to K023061 (2002). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042386: Direct Digitizer, Regius Model 190, Konica Minolta Medical & Graphic, Inc. (2004) Summary page 1.

## Most influential descendants
- K071181: Direct Digitizer, Regius Model 110 (2007), 2 descendants of its own
- K103703: Reguis Sigma (2011), 1 descendant of its own
- K120131: Regius SIGMA2 (2012), 0 descendants of its own
- K092717: Direct Digitizer, Regius Model 210 (2009), 0 descendants of its own

## Indications for use
The Direct Digitizer, REGIUS MODEL 190 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. REGIUS MODEL 190 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg. REGIUS MODEL 190 is also used to obtain image data to verify the position for a radiotherapy location. It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities. It is not intended for use with digital mammography system.

Source page: https://510kreport.com/device/K052095
Methodology: https://510kreport.com/methodology