510(k) · Cleared
ClearedSonosite LX and Sonosite PX Ultrasound Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Sonosite, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 29, 2025 as substantially equivalent to K233597 (FUJIFILM Sonosite, Inc., 2023) after a 140-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Aug 29, 2025
- Review
- 140 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K945773 (1995). 62 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet.
- Root · 19 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 15 generations between
- 3 generations backK200964 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020
- 2 generations backK213763 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021
- 1 generation backK233597 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023
- This deviceK251106 Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc. · 2025
Show all 19 generations
- Root · 19 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 18 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 17 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 16 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 15 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 14 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 13 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 12 generations backK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- 11 generations backK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- 10 generations backK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- 9 generations backK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- 8 generations backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- 7 generations backK153626 SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 6 generations backK160734 SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 5 generations backK162045 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 4 generations backK171437 SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2017
- 3 generations backK200964 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020
- 2 generations backK213763 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021
- 1 generation backK233597 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023
- This deviceK251106 Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −18 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −17 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −16 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −15 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −14 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −13 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| −12 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| −11 | K130173 | Sonosite Maxx Series Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | 1 |
| −10 | K133454 | Sonosite Edge Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | — |
| −9 | K142017 | X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2014 | — |
| −8 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| −7 | K153626 | SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −6 | K160734 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −5 | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −4 | K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2017 | — |
| −3 | K200964 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2020 | — |
| −2 | K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2021 | — |
| −1 | K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2023 | — |
| 0 (this device) | K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | FUJIFILM Sonosite, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233597 | Sonosite LX Ultrasound SystemSummary page 6…Page 1 of 14 4) Predicate Device: Primary Predicate: Sonosite LX Ultrasound System (K233597) Reference: Sonosite PX Ultrasound System (K213763) 5) Device Description: The Sonosite LX an… | 2023 |
| † | K213763 | Sonosite PX Ultrasound System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 62 ancestors have a recall of any class.
- 1 other device also cites its predicate K233597.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
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…
Read the full statement (244 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251106 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251106: Sonosite LX and Sonosite PX Ultrasound Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251106
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026