# K122329: Biojet

- Pathway: 510(k) (Traditional)
- Applicant: Jet Soft Srl
- Decided: Aug 16, 2012 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K954678 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081093: 3-D Imaging Workstation, Eigen, LLC (2008) Summary page 1.

## Indications for use
The BioJet software is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurements, and 3-D registration.

Source page: https://510kreport.com/device/K122329
Methodology: https://510kreport.com/methodology