510(k) · Cleared
Recalled · Class III · 2025IU22 Ultrasound System and Transducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 1, 2010 as substantially equivalent to K042540 (Philips Ultrasound, Inc., 2004) and 3 other predicates after a 75-day review. Its family tree reaches back 11 generations to 1995. 2 of the 654 devices in its family, counting itself, have a Class I recall. 588 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 1, 2010
- Review
- 75 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 11 generations to K935595 (1995). 65 ancestors in all, the oldest K891689 (1989). 588 later devices descend from it, 12 citing it directly. 2 of the 654 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010
- Descendant · cites it directly · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
- Descendant · 2 generations on · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
- Descendant · cites it directly · 405 of its ownK121329 AixplorerSupersonic Imagine · 2012
- Descendant · 2 generations on · 312 of its ownK132274 AixplorerSupersonic Imagine · 2013
- Descendant · 3 generations on · 263 of its ownK142160 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · Recalled
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010
Showing 5 of 588 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 588 · See all- K102041AixplorerSupersonic Imagine · 2010 · cites it directly527descendants
- K112255AixplorerSupersonic Imagine · 2012 · 2 generations on525descendants
- K121329AixplorerSupersonic Imagine · 2012 · cites it directly405descendants
- K132274AixplorerSupersonic Imagine · 2013 · 2 generations on312descendants
- K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · 3 generations on263descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −7 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −5 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −3 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −2 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −1 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| 0 (this device) | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | — |
| +1 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| +2 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| +1 | K121329 | Aixplorer | Supersonic Imagine | 2012 | — |
| +2 | K132274 | Aixplorer | Supersonic Imagine | 2013 | — |
| +3 | K142160 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 15 | 0 |
| 2014 | 16 | 0 |
| 2015 | 38 | 0 |
| 2016 | 40 | 0 |
| 2017 | 56 | 0 |
| 2018 | 47 | 0 |
| 2019 | 36 | 0 |
| 2020 | 53 | 0 |
| 2021 | 46 | 0 |
| 2022 | 44 | 0 |
| 2023 | 40 | 0 |
| 2024 | 47 | 0 |
| 2025 | 55 | 2 |
| 2026 | 41 | 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.
2 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? (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 |
|---|---|---|---|
| * | K042540 | Philips IU22 Ultrasound SystemSummary page 1…ally equivalent to the following currently marketed devices: Product 5109k Philips iU22 K042540 Siemens Acuson S2000 K072786 Philips QLAB K021966, K023877… | 2004 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 1…ices: Product 5109k Philips iU22 K042540 Siemens Acuson S2000 K072786 Philips QLAB K021966, K023877 510(k) Summary… | 2007 |
| * | K021966 | Q Lab SoftwareSummary page 1…09k Philips iU22 K042540 Siemens Acuson S2000 K072786 Philips QLAB K021966, K023877 510(k) Summary Page 1 5 1… | 2002 |
| * | K023877 | Q Lab Quantification Software with Strain Rate Quantification Plug-inSummary page 1…ilips iU22 K042540 Siemens Acuson S2000 K072786 Philips QLAB K021966, K023877 510(k) Summary Page 1 5 10(k) Prem… | 2002 |
What descends from it? (588)
See all 58812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102041 | Aixplorer | 2010 | 527 |
| K121329 | Aixplorer | 2012 | 405 |
| K130499 | IU22 Diagnostic Ultrasound System | 2013 | 212 |
| K132304 | Epiq Diagnostic Ultrasound System | 2013 | 211 |
| K103677 | M7/M7T Diagnostic Ultrasound System | 2011 | 123 |
| K121010 | M7/M7T Diagnostic Ultrasound System | 2012 | 107 |
| K120699 | DC-T6 Diagnostic Ultrasound System | 2012 | 103 |
| K133329 | Ugeo WS80A Diagnostic Ultrasound System | 2013 | 102 |
| K132171 | Aixplorer | 2013 | 64 |
| K142100 | Aixplorer | 2014 | 63 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1620-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2376-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
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.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 16 of the 65 ancestors have a recall of any class.
- Of its descendants, K102041 (Supersonic Imagine, 2010) has gone furthest, with 527 descendants of its own.
- 11 other devices also cite its predicate K042540.
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. 2010, 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 iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small…
Read the full statement (126 words)
The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Ophthalmic
Fetal
Intra-operative
Abdominal
Laparoscopic
Pediatric
Small Organ
Adult and Neonatal Cephalic
Trans-rectal
Trans-vaginal
Musculoskeletal
Urology
Cardiac (Adult, Pediatric, Trans-esophageal)
Fetal Echo
Peripheral Vessel
The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093563: IU22 Ultrasound System and Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093563
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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