# K111508: Trident Specimen Radiography System, Model : RC Tri-00001

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Aug 19, 2011 after 79 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: 4 generations back to K021113 (2002). 6 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083510: Kubtec Xpert 20, Kub Technologies, Inc. (2009) Summary page 1.
- K061361: Faxitron Digital Radiography System, Model DX-50, Faxitron X-Ray Corp. (2006) Summary page 1.

## Most influential descendants
- K122428: Faxitron Specien Radiography System (2012), 4 descendants of its own
- K182727: Trident HD Specimen Radiography System (2019), 3 descendants of its own
- K202713: TrueView 100 Pro (2020), 2 descendants of its own
- K170786: Faxitron Bioptics Speciemen Radiography System (2017), 2 descendants of its own
- K173309: Faxitron VisionCT (2018), 1 descendant of its own

## Indications for use
A cabinet x-ray system used to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Source page: https://510kreport.com/device/K111508
Methodology: https://510kreport.com/methodology