# K223267: SKR 3000

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta, Inc.
- Decided: Nov 17, 2022 after 24 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: 13 generations back to K981556 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213908: SKR 3000, Konica Minolta, Inc. (2022) Summary page 4.

## Indications for use
The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures. The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.

Source page: https://510kreport.com/device/K223267
Methodology: https://510kreport.com/methodology