# K163502: iSR'obot Biopsy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biobot Surgical Pte., Ltd.
- Decided: May 16, 2017 after 153 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875128 (1988). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970515: General Purpose Latex Transducer Covers, CIVCO Medical Instruments Co., Inc. (1997) Summary page 4.
- K041637: Targetscan Transrectal Ultrasound System, Envisioneering, LLC (2004) 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 Biopsy Kit (consisting of a needle guide, a probe sheath and a drape) is intended to be used with the iSR’obot Mona Lisa (K130944) for performing image guided transperineal biopsies of the prostate.

Source page: https://510kreport.com/device/K163502
Methodology: https://510kreport.com/methodology