# K160357: Trinity

- Pathway: 510(k) (Traditional)
- Applicant: Koelis
- Decided: May 2, 2016 after 84 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 134 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141261: Logiq S7 Expert, Logiq S7 Pro, GE Healthcare (2014) Summary page 7.
- K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option, Koelis (2013) Summary page 7.

## Most influential descendants
- K170521: Trinity/3D Prostate Suite (2017), 0 descendants of its own

## Indications for use
TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants. The device is indicated to generate, visualize and record 2D and 3D ultrasound images. In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ. Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.). Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.

Source page: https://510kreport.com/device/K160357
Methodology: https://510kreport.com/methodology