# K210955: Kubtec Mozart Supra (XPERT 84) Radiography System

- Pathway: 510(k) (Special)
- Applicant: Kub Technologies, Inc.
- Decided: Sep 20, 2021 after 174 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: 7 generations back to K941191 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200756: Kubtec Mozart Supra, Kub Technologies, Inc. (2020) Summary page 5.
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001, Hologic, Inc. (2011) Summary page 8.
- K193166: MAMMOMAT Revelation, Siemens Medical Solutions USA, Inc. (2020) Summary page 8.

## Indications for use
The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2-dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.

Source page: https://510kreport.com/device/K210955
Methodology: https://510kreport.com/methodology