# K041638: Targetscan Biopsy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Envisioneering, LLC
- Decided: Sep 2, 2004 after 77 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 K851831 (1985). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980122: Manan Soft Tissue Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 1.
- K033963: EP Deflectable Catheters, Ep Medsystems, Inc. (2004) Summary page 1.

## Most influential descendants
- K073399: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide (2007), 1 descendant of its own
- K081323: Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 (2008), 0 descendants 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/K041638
Methodology: https://510kreport.com/methodology