# K161109: iSR'obot MRI-US Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Biobot Surgical Pte., Ltd.
- Decided: Oct 6, 2016 after 169 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: 8 generations back to K930090 (1993). 86 ancestors in all.
2 later devices descend from it; 1 cites it directly.
6 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120187: Multi-Modality Image Fusion, Igt, LLC Dba Eigen (2012) Summary page 7.

## Most influential descendants
- K213411: iSR’obot Mona Lisa 2.0 (2021), 1 descendant of its own
- K232320: iSR`obot Mona Lisa 2.0 (2023), 0 descendants of its own

## Indications for use
The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.

Source page: https://510kreport.com/device/K161109
Methodology: https://510kreport.com/methodology