# K173309: Faxitron VisionCT

- Pathway: 510(k) (Traditional)
- Applicant: Faxitron Bioptics, LLC
- Decided: May 9, 2018 after 203 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 K021113 (2002). 13 ancestors in all.
1 later device descends from it; 1 cites 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)
- K170786: Faxitron Bioptics Speciemen Radiography System, Faxitron Bioptics, LLC (2017) Summary page 5.
- K153583: BioVision Plus, Faxitron Bioptics, LLC (2016) Summary page 5.
- K071233: Xpert 40 Specimen Radiography System, Kub Technologies, Inc. (2007) Summary page 5.

## Most influential descendants
- K192939: Volumetric Specimen Imager (2019), 0 descendants of its own

## Indications for use
The Faxitron VisionCT is a Cabinet x-ray system that is used to provide two and three dimensional 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/K173309
Methodology: https://510kreport.com/methodology