510(k) · Cleared
ClearedSonosite MT Ultrasound System
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 Nov 3, 2025 as substantially equivalent to K251830 (FUJIFILM Sonosite, Inc., 2025) after a 32-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Nov 3, 2025
- Review
- 32 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K945773 (1995). 63 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet.
- Root · 20 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 16 generations between
- 3 generations backK213763 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021
- 2 generations backK233597 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023
- 1 generation backK251830 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2025
- This deviceK253448 Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc. · 2025
Show all 20 generations
- Root · 20 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 19 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 18 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 17 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 16 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 15 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 14 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 13 generations backK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- 12 generations backK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- 11 generations backK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- 10 generations backK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- 9 generations backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- 8 generations backK153626 SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 7 generations backK160734 SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 6 generations backK162045 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 5 generations backK171437 SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2017
- 4 generations backK200964 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020
- 3 generations backK213763 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021
- 2 generations backK233597 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023
- 1 generation backK251830 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2025
- This deviceK253448 Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −19 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −18 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −17 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −16 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −15 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −14 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| −13 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| −12 | K130173 | Sonosite Maxx Series Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | 1 |
| −11 | K133454 | Sonosite Edge Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | — |
| −10 | K142017 | X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2014 | — |
| −9 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| −8 | K153626 | SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −7 | K160734 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −6 | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −5 | K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2017 | — |
| −4 | K200964 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2020 | — |
| −3 | K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2021 | — |
| −2 | K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2023 | — |
| −1 | K251830 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2025 | — |
| 0 (this device) | K253448 | Sonosite MT Ultrasound System | 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 |
|---|---|---|---|
| * | K251830 | Sonosite LX Ultrasound SystemSummary page 6…ITX Device Class: Class II Classification Panel: Radiology 3) Predicate Device: Primary Predicate: Sonosite LX Ultrasound System (K251830) Regulation Name: Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transduce… | 2025 |
| † | K233597 | Sonosite LX Ultrasound System | 2023 |
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 63 ancestors have a recall of any class.
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 MT 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…
Read the full statement (207 words)
The Sonosite MT 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
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.
The Sonosite MT 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.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253448: Sonosite MT Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253448
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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