# K173312: ProBx Software

- Pathway: 510(k) (Traditional)
- Applicant: Harmonus, Inc.
- Decided: Mar 2, 2018 after 134 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: 7 generations back to K954678 (1996). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133030: Dynacad/Prostate Interventional (Dynaloc/Prostate), Invivo Corporation (2014) Summary page 5.

## Indications for use
ProBx Software is intended for use as follows: • ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices. • ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural and intra-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the target. The Software displays an MRI image of the current location of the interventional instrument for positioning confirmation. • ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate.

Source page: https://510kreport.com/device/K173312
Methodology: https://510kreport.com/methodology