# K041639: Targetscn Transrectal Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Envisioneering, LLC
- Decided: Sep 2, 2004 after 77 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: 1 generation back to K864807 (1987). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864807: Teknar Proscan (TM), Teknar, Inc. (1987) Summary page 1.

## Most influential descendants
- K111347: Isrobot Mona Lisa (2011), 4 descendants of its own
- K130944: Isr'obot Mona Lisa (2013), 3 descendants of its own
- 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
This Ultrasound imaging system is intended for transrectal diagnostic imaging of the prostate gland. This imaging can be used to guide other procedures such as biopsy of the prostate. This system is intended to be used with adult patients. This system is intended for use by medical professionals in a physician office or hospital environment.

Source page: https://510kreport.com/device/K041639
Methodology: https://510kreport.com/methodology