# K013054: Konica Direct Digitizer Regius Model 350

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Mar 1, 2002 after 171 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: 1 generation back to K980873 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980873: Konica Direct Digitizer Regius Model 330, Konica Corp. (1998) Summary page 1.

## Indications for use
The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.

Source page: https://510kreport.com/device/K013054
Methodology: https://510kreport.com/methodology