# K213763: Sonosite PX Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Dec 27, 2021 after 26 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: 17 generations back to K945773 (1995). 60 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K200964: Sonosite PX Ultrasound System, FUJIFILM Sonosite, Inc. (2020) Summary page 5.
- K162045: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 5.

## Most influential descendants
- K233597: Sonosite LX Ultrasound System (2023), 3 descendants of its own
- 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 PX 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 Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral Vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Transesophageal (cardiac) Transrectal Needle Guidance Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD The Sonosite PX Ultrasound 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.

Source page: https://510kreport.com/device/K213763
Methodology: https://510kreport.com/methodology