# K041637: Targetscan Transrectal Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Envisioneering, LLC
- Decided: Sep 1, 2004 after 76 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: 2 generations back to K875128 (1988). 3 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970514: Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide, CIVCO Medical Instruments Co., Inc. (1997) 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
- K163502: iSR'obot Biopsy Kit (2017), 2 descendants of its own
- K213411: iSR’obot Mona Lisa 2.0 (2021), 1 descendant of its own

## Indications for use
This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan model TS-360-P probe.

Source page: https://510kreport.com/device/K041637
Methodology: https://510kreport.com/methodology