# K212685: Konicaminolta DI-X1

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta, Inc.
- Decided: Sep 13, 2021 after 20 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: 1 generation back to K182431 (2018). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182431: Konicaminolta DI-X1, Konica Minolta, Inc. (2018) Summary page 4.

## Most influential descendants
- K253029: RW-1 (2026), 0 descendants of its own
- K232456: RW-1 (2025), 0 descendants of its own
- K230906: Konicaminolta DI-X1 (2023), 0 descendants of its own

## Indications for use
KONICAMINOLTA DI-XI1 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/K212685
Methodology: https://510kreport.com/methodology