# K183142: PathVisionXL

- Pathway: 510(k) (Traditional)
- Applicant: Faxitron Bioptics, LLC
- Decided: Mar 14, 2019 after 121 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: 6 generations back to K021113 (2002). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122428: Faxitron Specien Radiography System, Faxitron Bioptics, LLC (2012) Summary page 4.

## Indications for use
The PathVisionXL 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/K183142
Methodology: https://510kreport.com/methodology