# K033367: Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System, Model L03073, L02245, L02464

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Nov 5, 2003 after 15 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: 3 generations back to K850478 (1985). 14 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030949: Titan High Resolution Ultrasound System, Sonosite,Inc. (2003) Summary page 2.
- K021628: Sonosite Hand-Caried Untrasound System (Powerseries), Sonosite,Inc. (2002) Summary page 12.
- K014116: Hand-Carried Ultrasound System, Sonosite,Inc. (2001) Summary page 14.
- K993624: Site-Rite 3 Ultrasound System, Dymax Corp (1999) Summary page 2.

## Most influential descendants
- K100402: Site-Rite Vision Ultrasound System (2010), 10 descendants of its own
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (2012), 8 descendants of its own
- K132942: Site-Rite Vision II Ultrasound System (2013), 7 descendants of its own
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (2015), 6 descendants of its own
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), 4 descendants of its own

## Indications for use
The SonoSite ultrasound systems are intended for use for ultrasound evaluation of fetal - OB/GYN, abdominal, intra-operative (abdominal organs and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Source page: https://510kreport.com/device/K033367
Methodology: https://510kreport.com/methodology