# K130944: Isr'obot Mona Lisa

- Pathway: 510(k) (Special)
- Applicant: Biobot Surgical Pte., Ltd.
- Decided: Jun 7, 2013 after 64 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: 4 generations back to K875128 (1988). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111347: Isrobot Mona Lisa, Biobot Surgical Pte., Ltd. (2011) Summary page 1.

## Most influential descendants
- K203659: iSR'obot Mona Lisa 1.0 (2021), 2 descendants of its own
- 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
iSR’obot Mona Lisa is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports BMode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.

Source page: https://510kreport.com/device/K130944
Methodology: https://510kreport.com/methodology