# K210957: Kubec Xpert 80 Radiography System

- 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: 7 generations back to K941191 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071233: Xpert 40 Specimen Radiography System, Kub Technologies, Inc. (2007) Summary page 5.
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001, Hologic, Inc. (2011) Summary page 5.
- K193166: MAMMOMAT Revelation, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Indications for use
The Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various 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/K210957
Methodology: https://510kreport.com/methodology