510(k) · Cleared
ClearedExo Iris (El2001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exo Imaging, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 9, 2022 as substantially equivalent to K211527 (Exo Imaging, Inc., 2021) after a 110-day review. Its family tree reaches back 25 generations to 1995. 6 of the 278 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 9, 2022
- Review
- 110 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 25 generations to K935595 (1995). 277 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet. 6 of the 278 devices in this family, counting this one, have a Class I recall.
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations between
- 3 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 2 generations backK202406 Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 2020
- 1 generation backK211527 Exo IrisExo Imaging, Inc. · 2021
- This deviceK222198 Exo Iris (El2001)Exo Imaging, Inc. · 2022
Show all 25 generations
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 23 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 22 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 21 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 20 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 19 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 18 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 16 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 15 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 14 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 13 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 12 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 11 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 10 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 9 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 8 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 7 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 6 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 5 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 4 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 3 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 2 generations backK202406 Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 2020
- 1 generation backK211527 Exo IrisExo Imaging, Inc. · 2021
- This deviceK222198 Exo Iris (El2001)Exo Imaging, Inc. · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −24 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −23 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −22 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −21 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −20 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −19 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −18 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −16 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −15 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −14 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −13 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −12 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −11 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −10 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −9 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −8 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −7 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −6 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −5 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −4 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| −3 | K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | — |
| −2 | K202406 | Butterfly iQ Ultrasound System | Butterfly Network, Inc. | 2020 | — |
| −1 | K211527 | Exo Iris | Exo Imaging, Inc. | 2021 | — |
| 0 (this device) | K222198 | Exo Iris (El2001) | Exo Imaging, Inc. | 2022 | — |
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 | 8 | 0 |
| 1996 | 7 | 1 |
| 1997 | 11 | 0 |
| 1998 | 14 | 3 |
| 1999 | 16 | 0 |
| 2000 | 15 | 1 |
| 2001 | 16 | 0 |
| 2002 | 20 | 0 |
| 2003 | 18 | 0 |
| 2004 | 16 | 1 |
| 2005 | 16 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 11 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K211527 | Exo IrisSummary page 4…90 -1YO Diagnostic Ultrasound Transducer 892.1570 90 - ITX A. Legally Marketed Predicate Devices The predicate device is the Exo Iris, manufactured by Exo Imaging Inc. (K211527) cleared on 20™ August 2021. B. Reference Device The reference device is the Butterfly iQ Ultrasound System, manufactured by Bu… | 2021 |
| † | K202406 | Butterfly iQ Ultrasound System | 2020 |
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 · 10 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 10 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 10 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 27 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 81 of the 277 ancestors have a recall of any class; 6 have a Class I recall.
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. 2022, 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?
Exo Iris is indicated for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.
Modes of operation include: B-Mode, B-Mode + Color Doppler, B-Mode + M-Mode.
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/K222198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222198: Exo Iris (El2001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222198
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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