510(k) · Cleared
ClearedFUJIFILM SonoSite iViz 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 12, 2015 as substantially equivalent to K133454 (FUJIFILM Sonosite, Inc., 2013) and 1 other predicate after a 34-day review. Its family tree reaches back 17 generations to 1995. 6 of the 197 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Nov 12, 2015
- Review
- 34 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K935595 (1995). 191 ancestors in all, the oldest K850478 (1985). 5 later devices descend from it, 1 citing it directly. 6 of the 197 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations between
- 3 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 2 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 1 generation backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- This deviceK152983 FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK161119 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK162288 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK180704 SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK260595 Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK202160 Sonosite PX Ultrasound System, Sonosite SII Ultrasound System…FUJIFILM Sonosite, Inc. · 2020
Show all 17 generations
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 15 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 14 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 13 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 12 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 8 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 7 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 5 generations backK102041 AixplorerSupersonic Imagine · 2010
- 4 generations backK112255 AixplorerSupersonic Imagine · 2012
- 3 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 2 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 1 generation backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- This deviceK152983 FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016 · cites it directly4descendants
- K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016 · 2 generations on3descendants
- K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc. · 2018 · 3 generations on2descendants
- K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc. · 2026 · 4 generations on0descendants
- K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −16 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −15 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −14 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −13 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −12 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −11 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −7 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −5 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −4 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −3 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| −2 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| −1 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| 0 (this device) | K152983 | FUJIFILM SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| +1 | K161119 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +2 | K162288 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +3 | K180704 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2018 | — |
| +4 | K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | 2026 | — |
| +4 | 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K133454 | Sonosite Edge Ultrasound SystemSummary page 6…ucer 892.1570 90-ITX 3) Identification of the predicate or legally marketed device: SonoSite Edge Ultrasound System K133454 Philips Nuvis Ultrasound System K133833 4) Device Description: The SonoSite iViz Ultrasound System is a highly feature… | 2013 |
| * | K133833 | Nuvis Diagnostic Ultrasound SystemSummary page 6…90-ITX 3) Identification of the predicate or legally marketed device: SonoSite Edge Ultrasound System K133454 Philips Nuvis Ultrasound System K133833 4) Device Description: The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnost… | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161119 | SonoSite iViz Ultrasound System | 2016 | 4 |
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 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 5 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 20 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 51 of the 191 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K161119 (FUJIFILM Sonosite, Inc., 2016) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K133454.
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. 2015, 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 FUJIFILM SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care 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:
Fetal - OB
Abdominal
Pediatric
Cardiac Adult
Cardiac Pediatric
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152983: FUJIFILM SonoSite iViz 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/K152983
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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