# K061361: Faxitron Digital Radiography System, Model DX-50

- Pathway: 510(k) (Traditional)
- Applicant: Faxitron X-Ray Corp.
- Decided: Aug 15, 2006 after 91 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
No predicates in its family tree.
20 later devices descend from it; 3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071233: Xpert 40 Specimen Radiography System (2007), 18 descendants of its own
- K083510: Kubtec Xpert 20 (2009), 15 descendants of its own
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001 (2011), 14 descendants of its own
- K072557: Faxitron Specimen Radiography System, Model MX-20 (2007), 5 descendants of its own
- K122428: Faxitron Specien Radiography System (2012), 4 descendants of its own

## Indications for use
The DX-50 is a Cabinet x-ray system that is used to provide 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. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

Source page: https://510kreport.com/device/K061361
Methodology: https://510kreport.com/methodology