# K122428: Faxitron Specien Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Faxitron Bioptics, LLC
- Decided: Sep 25, 2012 after 47 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). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 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 1.
- K072557: Faxitron Specimen Radiography System, Model MX-20, Faxitron X-Ray Corp. (2007) Summary page 1.
- K091558: Biovision Digital Specimen Radiography System, Bioptics, Inc. (2009) Summary page 1.

## Most influential descendants
- K170786: Faxitron Bioptics Speciemen Radiography System (2017), 2 descendants of its own
- K173309: Faxitron VisionCT (2018), 1 descendant of its own
- K192939: Volumetric Specimen Imager (2019), 0 descendants of its own
- K183142: PathVisionXL (2019), 0 descendants of its own

## Indications for use
The PathVision is a Cabinet x-ray system that is used to provide film and/or 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/K122428
Methodology: https://510kreport.com/methodology