510(k) · Cleared
Recalled · Class III · 2025Lumify Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Health Care · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 6, 2019 as substantially equivalent to K162549 (Philips Health Care, 2016) after a 21-day review. Its family tree reaches back 19 generations to 1995. 8 of the 206 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 6, 2019
- Review
- 21 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 19 generations to K935595 (1995). 174 ancestors in all, the oldest K850478 (1985). 31 later devices descend from it, 9 citing it directly. 8 of the 206 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 2 generations backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- 1 generation backK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
- This deviceK192226 Lumify Diagnostic Ultrasound SystemPhilips Health Care · 2019
- Descendant · cites it directly · 18 of its ownK201012 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic…Philips Ultrasound, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 17 of its ownK211597 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic…Philips Medical Systems · 2021
- Descendant · 3 generations on · 16 of its ownK233788 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic…Philips Ultrasound, LLC · 2024 · Recalled
- Descendant · 4 generations on · 14 of its ownK240850 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series…Philips Ultrasound, LLC · 2024
- Descendant · 5 generations on · 5 of its ownK243794 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic…Philips Ultrasound, LLC · 2025
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 10 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 9 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 7 generations backK102041 AixplorerSupersonic Imagine · 2010
- 6 generations backK112255 AixplorerSupersonic Imagine · 2012
- 5 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 4 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 3 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 2 generations backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- 1 generation backK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
- This deviceK192226 Lumify Diagnostic Ultrasound SystemPhilips Health Care · 2019
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc. · 2020 · cites it directly18descendants
- K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems · 2021 · 2 generations on17descendants
- K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2024 · 3 generations on16descendants
- K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · 2024 · 4 generations on14descendants
- K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2025 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −10 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −9 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −7 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −6 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −5 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| −4 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| −3 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| −2 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| −1 | K162549 | Lumify Ultrasound System | Philips Health Care | 2016 | 6 |
| 0 (this device) | K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | 2019 | — |
| +1 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound… | Philips Ultrasound, Inc. | 2020 | 5 |
| +2 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic… | Philips Medical Systems | 2021 | — |
| +3 | K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic… | Philips Ultrasound, LLC | 2024 | 1 |
| +4 | K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic… | Philips Ultrasound, LLC | 2024 | — |
| +5 | K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic… | Philips Ultrasound, LLC | 2025 | — |
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 | 9 | 0 |
| 1998 | 13 | 3 |
| 1999 | 16 | 0 |
| 2000 | 14 | 1 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 1 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 11 | 2 |
| 2026 | 7 | 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.
8 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 |
|---|---|---|---|
| * | K162549 | Lumify Ultrasound SystemSummary page 4…device: Predicate Device 510(k) Lumify Ultrasound System K162549 Traditional 510(k) Philips Ultrasound, Inc. Lumify… | 2016 |
What descends from it? (31)
See all 319 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series… | 2020 | 18 |
| K203406 | Lumify Diagnostic Ultrasound System | 2021 | 4 |
| K242519 | Lumify Diagnostic Ultrasound System Class I | 2025 | 0 |
| K242670 | Lumify Diagnostic Ultrasound System Class I | 2025 | 0 |
| K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital… | 2021 | 0 |
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | 2021 | 0 |
| K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | 2021 | 0 |
| K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | 2021 | 0 |
| K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | 2021 | 0 |
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1625-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2354-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2374-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2392-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2391-2025 | 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 7 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 7 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 7 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · Cites it directly · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · Cites it directly · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 45 of the 174 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K201012 (Philips Ultrasound, Inc., 2020) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K162549.
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. 2019, 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?
Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac.
Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192226: Lumify Diagnostic 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/K192226
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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