# K210956: Kubtec Mozart (XPERT42)

- Pathway: 510(k) (Special)
- Applicant: Kub Technologies, Inc.
- Decided: Aug 31, 2021 after 154 days
- Product code: MWP (Cabinet, X-Ray System)
- 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: 5 generations back to K021113 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183624: Kubtec Mozart (Xpert42), Kub Technologies, Inc. (2019) Summary page 5.
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001, Hologic, Inc. (2011) Summary page 7.

## Indications for use
The MOZART (XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. It is not used for mammography

Source page: https://510kreport.com/device/K210956
Methodology: https://510kreport.com/methodology