# K230906: Konicaminolta DI-X1

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta, Inc.
- Decided: Apr 25, 2023 after 25 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K182431 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212685: Konicaminolta DI-X1, Konica Minolta, Inc. (2021) Summary page 4.

## Indications for use
KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. R/F Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. It is not intended for use in diagnostic review for mammography.

Source page: https://510kreport.com/device/K230906
Methodology: https://510kreport.com/methodology