# K241319: SKR 3000

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta, Inc.
- Decided: Nov 21, 2024 after 195 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: 9 generations back to K981556 (1998). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151465: AeroDR SYSTEM 2, Konica Minolta, Inc. (2015) Summary page 5.

## Most influential descendants
- K250665: SKR 3000 (2025), 0 descendants of its own

## 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. The P-53 is for adult use only.

Source page: https://510kreport.com/device/K241319
Methodology: https://510kreport.com/methodology