# K251106: Sonosite LX and Sonosite PX Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Aug 29, 2025 after 140 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: 19 generations back to K945773 (1995). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233597: Sonosite LX Ultrasound System, FUJIFILM Sonosite, Inc. (2023) Summary page 6.

## Indications for use
The Sonosite LX and Sonosite PX ultrasound systems are general purpose ultrasound systems 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 - O8/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 and Sonosite PX ultrasound systems are intended to be used in medical practices, clinical environments, including healthcare facilities, hospitals, clinics, and clinical point-of-care for diagnosis of patients. The systems are used with a transducers attached and they are 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/K251106
Methodology: https://510kreport.com/methodology