# K191645: SKR 4000

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta, Inc.
- Decided: Aug 16, 2019 after 58 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: 11 generations back to K981556 (1998). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160810: ViZion DR + Wireless, Viztek, LLC (2016) Summary page 4.
- K182688: SKR 3000, Konica Minolta, Inc. (2018) Summary page 4.

## Indications for use
The SKR 4000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in general-purpose diagnostic procedures. The SKR 4000 is not indicated for use in mammography, fluoroscopy, and angiography applications.

Source page: https://510kreport.com/device/K191645
Methodology: https://510kreport.com/methodology