510(k) · Cleared
ClearedFUJIFILM FC1 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 Mar 16, 2016 as substantially equivalent to K133454 (FUJIFILM Sonosite, Inc., 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 12 generations to 1995. 12 later devices descend from it.
- Decided
- Mar 16, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K945773 (1995). 54 ancestors in all, the oldest K891689 (1989). 12 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 8 generations between
- 3 generations backK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- 2 generations backK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- 1 generation backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- This deviceK160406 FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · cites it directly · 11 of its ownK162045 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · 2 generations on · 7 of its ownK171437 SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK200964 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK213763 Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK233597 Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 11 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 10 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 9 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 8 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 7 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 6 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 5 generations backK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- 4 generations backK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- 3 generations backK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- 2 generations backK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- 1 generation backK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- This deviceK160406 FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016 · cites it directly11descendants
- K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2017 · 2 generations on7descendants
- K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020 · 2 generations on6descendants
- K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021 · 2 generations on4descendants
- K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −11 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −10 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −9 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −8 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −7 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −6 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| −5 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| −4 | K130173 | Sonosite Maxx Series Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | 1 |
| −3 | K133454 | Sonosite Edge Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | — |
| −2 | K142017 | X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2014 | — |
| −1 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| 0 (this device) | K160406 | FUJIFILM FC1 Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +1 | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +2 | K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2017 | — |
| +2 | K200964 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2020 | — |
| +2 | K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2021 | — |
| +2 | K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 14…ansducer 892.1570 90-ITX 3) Identification of the predicate or legally marketed device: SonoSite Edge Ultrasound System K133454 (primary predicate device) SonoSite X-Porte Ultrasound System K152209 4) Device Description: The FC1 Ultrasound System is… | 2013 |
| * | K152209 | FUJIFILM SonoSite X-Porte Ultrasound SystemSummary page 14…fication of the predicate or legally marketed device: SonoSite Edge Ultrasound System K133454 (primary predicate device) SonoSite X-Porte Ultrasound System K152209 4) Device Description: The FC1 Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultraso… | 2015 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | 2016 | 11 |
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 1.3 years on median.
- 13 of the 54 ancestors have a recall of any class.
- Of its descendants, K162045 (FUJIFILM Sonosite, Inc., 2016) has gone furthest, with 11 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. 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 FUJIFILM FC1Ultrasound 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:
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
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/K160406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160406: FUJIFILM FC1 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/K160406
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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