# K233597: Sonosite LX Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Dec 6, 2023 after 28 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: 18 generations back to K945773 (1995). 61 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213763: Sonosite PX Ultrasound System, FUJIFILM Sonosite, Inc. (2021) Summary page 6.
- K162045: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 6.

## Most influential descendants
- K251830: Sonosite LX Ultrasound System (2025), 1 descendant of its own
- K253448: Sonosite MT Ultrasound System (2025), 0 descendants of its own
- K251106: Sonosite LX and Sonosite PX Ultrasound Systems (2025), 0 descendants of its own

## Indications for use
The Sonosite LX ultrasound system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal Adult Cephalic Neonatal Cephalic Cardiac Adult Cardiac Pediatric Fetal – OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transesophageal (cardiac) Transrectal Transvaginal Needle Guidance Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD. This device is indicated for Prescription Use Only. The Sonosite LX system is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients. The system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient’s body where needed to obtain the desired ultrasound image.

Source page: https://510kreport.com/device/K233597
Methodology: https://510kreport.com/methodology