# K153166: Fusion Bx

- Pathway: 510(k) (Traditional)
- Applicant: Focal Healtcare, Inc.
- Decided: Jan 25, 2016 after 84 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.
1 later device descends from it; 1 cites it directly.
0 of 12 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 6.

## Most influential descendants
- K181290: Fusion Bx 2.0 (2018), 0 descendants of its own

## Indications for use
Fusion Bx is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, image measurement, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and to record the locations where the biopsies were acquired during the procedure.

Source page: https://510kreport.com/device/K153166
Methodology: https://510kreport.com/methodology