# K123901: Tractus Tissuemapper Reviewer Application

- Pathway: 510(k) (Traditional)
- Applicant: Tractus Corporation
- Decided: Jan 29, 2013 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 69 ancestors in all.
2 later devices descend from it; 1 cites it directly.
6 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093672: Aegis Navigation Anda Egis Pelvic Application, Sentinelle Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K171709: BR-FHUS Viewer 1.0 (2017), 1 descendant of its own
- K211098: Breast Volume Navigator (BVN) Model G-2000 (2021), 0 descendants of its own

## Indications for use
The Tractus TissueMapper Reviewer Application provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. The supported imaging modality is Ultrasound (US). Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices. This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to imaging probes or other tracked devices. This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures; including head and neck, breast, thoracic, and abdominal applications

Source page: https://510kreport.com/device/K123901
Methodology: https://510kreport.com/methodology