# K092717: Direct Digitizer, Regius Model 210

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Oct 30, 2009 after 57 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: 3 generations back to K023061 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052095: Modification to: Direct Digitizer Regius Model 190, Konica Minolta Medical & Graphic, Inc. (2005) Summary page 1.

## Indications for use
The Direct Digitizer, REGIUS Model 210 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 210 also reads the image data of long areas of anatomy and to verify the position for a radiotherapy location. 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 with FFDM systems

Source page: https://510kreport.com/device/K092717
Methodology: https://510kreport.com/methodology