510(k) · Cleared
ClearedSonoSite SII Ultrasound System, SonoSite Edge II 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 Aug 18, 2016 as substantially equivalent to K153626 (FUJIFILM Sonosite, Inc., 2016) and 3 other predicates after a 24-day review. Its family tree reaches back 14 generations to 1995. 11 later devices descend from it.
- Decided
- Aug 18, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K945773 (1995). 57 ancestors in all, the oldest K891689 (1989). 11 later devices descend from it, 7 citing it directly.
- Root · 14 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 10 generations between
- 3 generations backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- 2 generations backK153626 SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 1 generation backK160734 SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- This deviceK162045 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK171437 SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK200964 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK213763 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK233597 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK180704 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2018
Show all 14 generations
- Root · 14 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 13 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 12 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 11 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 10 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 9 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 8 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 7 generations backK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- 6 generations backK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- 5 generations backK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- 4 generations backK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- 3 generations backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- 2 generations backK153626 SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- 1 generation backK160734 SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- This deviceK162045 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2017 · cites it directly7descendants
- K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020 · cites it directly6descendants
- K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021 · cites it directly4descendants
- K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023 · cites it directly3descendants
- K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −13 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −12 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −11 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −10 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −9 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −8 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| −7 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| −6 | K130173 | Sonosite Maxx Series Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | 1 |
| −5 | K133454 | Sonosite Edge Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | — |
| −4 | K142017 | X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2014 | — |
| −3 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| −2 | K153626 | SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −1 | K160734 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| 0 (this device) | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +1 | K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2017 | — |
| +1 | K200964 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2020 | — |
| +1 | K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2021 | — |
| +1 | K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2023 | — |
| +1 | K180704 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K153626 | SonoSite Edge II Ultrasound SystemSummary page 4…I) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked “P” were previously cleared in 510(k) K153626 (Edge II). Prescription Use (Per 21 CFR 801.109) Page 2 of 31… | 2016 |
| * | K160734 | SonoSite SII Ultrasound SystemSummary page 20…I) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked “P” were previously cleared in 510(k) K160734 (SII). Prescription Use (Per 21 CFR 801.109) Page 18 of 31… | 2016 |
| * | K133454 | Sonosite Edge Ultrasound SystemSummary page 5…I) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked “P” were previously cleared in 510(k) K133454 (Edge). Prescription Use (Per 21 CFR 801.109) Page 3 of 31… | 2013 |
| * | K160406 | FUJIFILM FC1 Ultrasound SystemSummary page 7…I) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked “P” were previously cleared in 510(k) K160406 (FC1). Prescription Use (Per 21 CFR 801.109) Page 5 of 31… | 2016 |
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171437 | SonoSite X-Porte Ultrasound System | 2017 | 7 |
| K200964 | Sonosite PX Ultrasound System | 2020 | 6 |
| K213763 | Sonosite PX Ultrasound System | 2021 | 4 |
| K233597 | Sonosite LX Ultrasound System | 2023 | 3 |
| K180704 | SonoSite iViz Ultrasound System | 2018 | 2 |
| K183235 | SonoSite SII Ultrasound System | 2019 | 1 |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound… | 2020 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 57 ancestors have a recall of any class.
- Of its descendants, K171437 (FUJIFILM Sonosite, Inc., 2017) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K153626.
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. 2016, 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 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…
Read the full statement (137 words)
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
Peripheral Vessel
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162045: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162045
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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