# K182727: Trident HD Specimen Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jan 10, 2019 after 104 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). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001, Hologic, Inc. (2011) Summary page 4.

## Most influential descendants
- K202713: TrueView 100 Pro (2020), 2 descendants of its own
- K230140: TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) (2023), 0 descendants of its own
- K230136: TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (2023), 0 descendants 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/K182727
Methodology: https://510kreport.com/methodology