# K170521: Trinity/3D Prostate Suite

- Pathway: 510(k) (Traditional)
- Applicant: Koelis
- Decided: May 30, 2017 after 97 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: 22 generations back to K935595 (1995). 184 ancestors in all.
No later device cites it as a predicate yet.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160357: Trinity, Koelis (2016) Summary page 11.
- K160182: LOGIQ S7 Expert, GE Healthcare (2016) Summary page 11.

## Indications for use
Ultrasound System TRINITY and its embedded 3D PROSTATE SUITE software are intended to be used by clinicians and their assistants, qualified to perform ultrasound diagnosis and ultrasound-guided procedures, in public or private hospitals. TRINITY is indicated to: * Generate ultrasound images for structural analysis and fluid flow analysis for o urology, o gynecology, o vascular, o abdominal, o small organs, o soft tissues and o musculoskeletal exams TRINITY is not indicated for ophthalmic and cranial ultrasonography. Medical Imaging Processing System 3D-PROSTATE SUITE, embedded on TRINITY or other KOELIS systems that do not integrate a 3D ultrasound module, is indicated to: * Process, visualize and record various 2D and 3D image modalities (such as Ultrasound images, MRI) * Fuse images of various modalities * Display organ and perform measurements * Display cartographies of prostate interventions (instrument positions) » Manage patient data * Import and export of data and images

Source page: https://510kreport.com/device/K170521
Methodology: https://510kreport.com/methodology