# K232320: iSR`obot Mona Lisa 2.0

- Pathway: 510(k) (Special)
- Applicant: Biobot Surgical Pte., Ltd.
- Decided: Dec 21, 2023 after 140 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K930090 (1993). 100 ancestors in all.
No later device cites it as a predicate yet.
6 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213411: iSR’obot Mona Lisa 2.0, Biobot Surgical Pte., Ltd. (2021) Summary page 5.

## Indications for use
iSR’obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations. The iSR’obot Mona Lisa 2.0 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool taking into account patient movement. Other software features include multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.

Source page: https://510kreport.com/device/K232320
Methodology: https://510kreport.com/methodology