# K020112: 50S Tringa Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Apr 19, 2002 after 98 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K944287 (1995). 3 ancestors in all.
112 later devices descend from it; 6 cite it directly.
2 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002357: 100 S and 100 LC and 485 Anser Ultrasound Imaging Systems, Pie Medical (2000) Summary page 1.
- K981293: 7200 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 1.

## Most influential descendants
- K090505: Speq Ultrasound System (2009), 107 descendants of its own
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own
- K162549: Lumify Ultrasound System (2016), 43 descendants of its own

## Indications for use
Pie Medical’s 50S Tringa ultrasound system is used by or under the direction of a physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, small organ & cardiac applications.

Source page: https://510kreport.com/device/K020112
Methodology: https://510kreport.com/methodology