510(k) · Cleared
ClearedSonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx 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 Sep 1, 2020 as substantially equivalent to K200964 (FUJIFILM Sonosite, Inc., 2020) and 5 other predicates after a 29-day review. Its family tree reaches back 21 generations to 1995. 6 of the 206 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 1, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 21 generations to K935595 (1995). 205 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet. 6 of the 206 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations between
- 3 generations backK161119 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 2 generations backK162288 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 1 generation backK180704 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2018
- This deviceK202160 Sonosite PX Ultrasound System, Sonosite SII Ultrasound System…FUJIFILM Sonosite, Inc. · 2020
Show all 21 generations
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 19 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 18 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 17 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 16 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 15 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 12 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 11 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 10 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 9 generations backK102041 AixplorerSupersonic Imagine · 2010
- 8 generations backK112255 AixplorerSupersonic Imagine · 2012
- 7 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 6 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 5 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 4 generations backK152983 FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- 3 generations backK161119 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 2 generations backK162288 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 1 generation backK180704 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2018
- This deviceK202160 Sonosite PX Ultrasound System, Sonosite SII Ultrasound System…FUJIFILM Sonosite, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −20 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −19 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −18 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −17 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −16 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −15 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −12 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −11 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −10 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −9 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −8 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −7 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| −6 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| −5 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| −4 | K152983 | FUJIFILM SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| −3 | K161119 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −2 | K162288 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −1 | K180704 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2018 | — |
| 0 (this device) | K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz… | FUJIFILM Sonosite, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 1 |
| 1997 | 10 | 0 |
| 1998 | 13 | 3 |
| 1999 | 16 | 0 |
| 2000 | 14 | 1 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 1 |
| 2005 | 11 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
6 devices in this family have a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | K200964 | Sonosite PX Ultrasound SystemSummary page 10…ucer Picture Archiving and 892.2050 LLZ Communications System III. Predicate Device: Sonosite PX Ultrasound System (K200964) Sonosite iViz Ultrasound System (K180704) Sonosite Edge II Ultrasound System (K162045) Sonosite X-Porte Ultrasound System (K1714… | 2020 |
| * | K180704 | SonoSite iViz Ultrasound SystemSummary page 10…892.2050 LLZ Communications System III. Predicate Device: Sonosite PX Ultrasound System (K200964) Sonosite iViz Ultrasound System (K180704) Sonosite Edge II Ultrasound System (K162045) Sonosite X-Porte Ultrasound System (K171437) Sonosite SII Ultrasound System (K18323… | 2018 |
| * | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemSummary page 10…Communications System III. Predicate Device: Sonosite PX Ultrasound System (K200964) Sonosite iViz Ultrasound System (K180704) Sonosite Edge II Ultrasound System (K162045) Sonosite X-Porte Ultrasound System (K171437) Sonosite SII Ultrasound System (K183235) Sonosite Maxx Ultrasound System (K130173)… | 2016 |
| * | K171437 | SonoSite X-Porte Ultrasound SystemSummary page 10…evice: Sonosite PX Ultrasound System (K200964) Sonosite iViz Ultrasound System (K180704) Sonosite Edge II Ultrasound System (K162045) Sonosite X-Porte Ultrasound System (K171437) Sonosite SII Ultrasound System (K183235) Sonosite Maxx Ultrasound System (K130173) IV. Device Description The Sonosite Di… | 2017 |
| * | K183235 | SonoSite SII Ultrasound SystemSummary page 10…0964) Sonosite iViz Ultrasound System (K180704) Sonosite Edge II Ultrasound System (K162045) Sonosite X-Porte Ultrasound System (K171437) Sonosite SII Ultrasound System (K183235) Sonosite Maxx Ultrasound System (K130173) IV. Device Description The Sonosite Diagnostic Ultrasound Systems are full feat… | 2019 |
| * | K130173 | Sonosite Maxx Series Ultrasound SystemSummary page 10…0704) Sonosite Edge II Ultrasound System (K162045) Sonosite X-Porte Ultrasound System (K171437) Sonosite SII Ultrasound System (K183235) Sonosite Maxx Ultrasound System (K130173) IV. Device Description The Sonosite Diagnostic Ultrasound Systems are full featured, general purpose, software controlled… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 9 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 9 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 9 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 51 of the 205 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K200964.
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. 2020, 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 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…
Read the full statement (448 words)
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
Needle Guidance
This device is indicated for Prescription Use Only.
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.
The SonoSite SII 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:
Ophthalmic
Fetal - OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:
Fetal - OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel
Ophthalmic
The SonoSite X-Porte 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:
Ophthalmic
Fetal – OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Peripheral Vessel
The SonoSite Edge II 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:
Ophthalmic
Fetal - OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
The SonoSite Maxx Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include:
Ophthalmic, Fetal - OB/GYN, Abdominal, lntraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202160 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202160: Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202160
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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