510(k) · Cleared
Recalled · Class II · 2025CX50 Diagnostic Ultrasound System, Sparq 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 14, 2016 as substantially equivalent to K123754 (Philips Ultrasound, Inc., 2012) and 1 other predicate after a 26-day review. Its family tree reaches back 17 generations to 1995. 6 of the 165 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 14, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 17 generations to K935595 (1995). 137 ancestors in all, the oldest K882383 (1988). 27 later devices descend from it, 6 citing it directly. 6 of the 165 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 backK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- This deviceK162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016
- 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 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 backK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- This deviceK162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · 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 |
|---|---|---|---|---|---|
| −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 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
| 0 (this device) | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | Philips Health Care | 2016 | — |
| +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 |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 1 |
| 1997 | 6 | 0 |
| 1998 | 10 | 3 |
| 1999 | 11 | 0 |
| 2000 | 13 | 1 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 10 | 0 |
| 2004 | 11 | 1 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K123754 | CX50 3.0 Diagnostic Ultrasound SystemSummary page 5…9. Infertility monitoring of follicle development Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: K123754 - CX50 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiologica… | 2012 |
| * | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Summary page 19…9. Infertility monitoring of follicle development Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD Previous submission: S7-3t cleared in K160807 – EPIQ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiologica… | 2016 |
What descends from it? (27)
See all 276 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 |
| K172056 | InnoSight Diagnostic Ultrasound System | 2017 | 2 |
| K190120 | Vinno 8, Vinno 6, Vinno 5 | 2020 | 1 |
| K163020 | Xperius Ultrasound System | 2016 | 1 |
| K250030 | Flash Ultrasound System 5100 Point of Care | 2025 | 0 |
| K192254 | InnoSight Diagnostic Ultrasound System | 2019 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2025 | Class III | Z-2370-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2361-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Aug 30, 2019 | Class II | Z-1841-2020 | Process control | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of… |
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 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 48 of the 137 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.
- 2 other devices also cite its predicate K123754.
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?
Philips CX50 Diagnostic Ultrasound Systems 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 and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult…
Read the full statement (147 words)
Philips CX50 Diagnostic Ultrasound Systems 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 and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Ophthalmic
Intraoperative
Laparoscopic
Fetal
Abdominal
Pediatric
Small Organ
Adult Cephalic
Neonatal Cephalic
Trans-vaginal
Musculo-skeletal
Gynecological
Cardiac Adult
Cardiac Pediatric
Trans-Esoph. (Cardiac)
Intracardiac echo
Peripheral Vessel
Other (Carotid)
Philips Sparq 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 and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Ophthalmic
Fetal
Abdominal
Pediatric
Small Organ
Adult Cephalic
Trans-vaginal
Trans-rectal
Musculo-skeletal
Gynecological
Cardiac Adult
Trans-Esoph. (Cardiac)
Peripheral Vessel
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162329: CX50 Diagnostic Ultrasound System, Sparq 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/K162329
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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