# K033604: Tringa Ultrasound Imaging System, Model 50L

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Dec 15, 2003 after 28 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: 3 generations back to K944287 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020112: 50S Tringa Ultrasound Imaging System, Pie Medical (2002) Summary page 1.
- K021628: Sonosite Hand-Caried Untrasound System (Powerseries), Sonosite,Inc. (2002) Summary page 1.

## Indications for use
Pie Medical's 50L Tringa ultrasound system is to be used by or under the direction of a physician to perform general non-invasive and invasive diagnostic ultrasound imaging studies, to include: abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular and musculoskeletal (conventional and superficial). The system provides ultrasound guidance for freehand or biopsy guided placement of needles and catheters in vascular or other anatomical structures.

Source page: https://510kreport.com/device/K033604
Methodology: https://510kreport.com/methodology