# K030949: Titan High Resolution Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Apr 7, 2003 after 12 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: 2 generations back to K945773 (1995). 5 ancestors in all.
683 later devices descend from it; 4 cite it directly.
0 of 689 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability, Advanced Technology Laboratories, Inc. (2001)
- K011188: GE Logiq 9, Model 2188900-X, GE Medical Systems (2001)
- K020353: Omnia X/XS Ultrasound System, Siemens Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) (2005), 678 descendants of its own
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), 676 descendants of its own
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K080223: Zura Tee System (2008), 583 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own

## Indications for use
The intended uses of the SonoSite TITAN high-resolution ultrasound system as defined by FDA guidance documents, are: Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Laparoscopic Pediatric Small Organ (breast, thyroid, testicles.) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Musculo-skel. (Conventional) Musculo-skel. (Superficial) Cardiac Adult Cardiac Pediatric Peripheral vessel

Source page: https://510kreport.com/device/K030949
Methodology: https://510kreport.com/methodology