# K181290: Fusion Bx 2.0

- Pathway: 510(k) (Special)
- Applicant: Focal Healthcare, Inc.
- Decided: Jun 15, 2018 after 30 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: 6 generations back to K954678 (1996). 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)
- K153166: Fusion Bx, Focal Healtcare, Inc. (2016) Summary page 4.

## Indications for use
Fusion Bx 2.0 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/K181290
Methodology: https://510kreport.com/methodology