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Radiology · 510(k) · 2025

Sonosite LX and Sonosite PX Ultrasound Systems

Fujifilm Sonosite Inc. Cleared by FDA on 29 August 2025 under submission K251106, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.

Device record · K251106

  1. Device. Sonosite LX and Sonosite PX Ultrasound SystemsDEVICE
  2. Company. Fujifilm Sonosite IncCOMPANY
  3. Decision. 29 August 2025, 510(k), substantially equivalent (traditional review); received 11 April 2025DECISION
  4. Panel. RadiologyPANEL
  5. Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
  6. Regulation. 21 CFR 892.1550, Class IIREG
  7. Source. FDA database entry · decision document (18 pages)SOURCE

Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.

What FDA cleared it for

The Indications for Use statement, verbatim, from the decision document.

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. Please provide the device trade name(s). Sonosite LX and Sonosite PX Ultrasound Systems I Please provide your Indications for Use below. K251106 ? ? ? 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 (Co nventional) • Musculo-skele tal (Superficial) • Ophthalmic • Pediatric • Peripheral vessel • Small Organ (breast, thyroid, testicles, prostate) • Transesophageal (cardiac) • Transrect al • Transvaginal • Needle Guidance Modes of opera tion 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), Con tinuous 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 […]

K251106, FDA decision document · source

What the statement says

Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.

Adverse-event reports in MAUDE, by product code

As of , MAUDE held 2,748 reports filed against devices carrying product code IYN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:

30 September 2026 · Malfunction · ACUSON Origin Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00096

30 September 2026 · Malfunction · ACUSON Sequoia Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00097

30 September 2026 · Malfunction · AFFINITI 30 · Philips Ultrasound, Inc · report 3019216-2026-100325

30 September 2026 · Injury · EPIQ 5G · Philips Ultrasound, Inc · report 3019216-2026-100326

29 September 2026 · Malfunction · ACUSON Juniper · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00091

One of the patient exams performed on the Juniper system displays an "Unarchived" error message and they are unable to send this study to PACS. All other exams performed before are after this one are transferring over to the PACS as expected without any errors. The problem occurred after a Breast study was completed and the user tried to send it over to the network PACS. TSE worked with the customer and she confirmed that the problem cannot be reproduced, as it only is affecting this one exam. […]

Where this fits

This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.

More devices under product code IYN, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.

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