510(k) · Cleared
Recalled · Class II · 2025CX50 Diagnostic Ultrasound System
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 Jun 24, 2011 as substantially equivalent to K091804 (Philips Ultrasound, Inc., 2009) and 2 other predicates after a 23-day review. Its family tree reaches back 5 generations to 2000. 56 later devices descend from it. It has been recalled 10 times.
- Decided
- Jun 24, 2011
- Review
- 23 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 10
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000695 (2000). 11 ancestors in all, the oldest K961459 (1997). 56 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 4 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 3 generations backK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
- 2 generations backK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
- 1 generation backK081802 CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2008 · Recalled
- This deviceK111513 CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2011
- Descendant · cites it directly · 53 of its ownK123754 CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 27 of its ownK162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · Recalled
- Descendant · 2 generations on · 19 of its ownK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
- Descendant · 3 generations on · 18 of its ownK201012 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic…Philips Ultrasound, Inc. · 2020 · Recalled
- Descendant · 4 generations on · 17 of its ownK211597 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic…Philips Medical Systems · 2021
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K123754CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2012 · cites it directly53descendants
- K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · 2 generations on27descendants
- K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015 · 2 generations on19descendants
- K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc. · 2020 · 3 generations on18descendants
- K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems · 2021 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −4 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −3 | K033139 | GE Marlin Ultrasound | General Electric Co. | 2003 | 1 |
| −2 | K061525 | GE Vivid - I | General Electric Co. | 2006 | 1 |
| −1 | K081802 | CX50 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2008 | 4 |
| 0 (this device) | K111513 | CX50 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2011 | — |
| +1 | K123754 | CX50 3.0 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2012 | 22 |
| +2 | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | Philips Health Care | 2016 | 3 |
| +2 | K142710 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015 | — |
| +3 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound… | Philips Ultrasound, Inc. | 2020 | 5 |
| +4 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic… | Philips Medical Systems | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 10 | 0 |
| 2026 | 8 | 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? (3)
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 |
|---|---|---|---|
| * | K091804 | CX50 Version 2.0 Diagnostic Ultrasound System and TransducersSummary page 1…92.1570 Transducer, Ultrasonic, diagnostic 90 ITX 3)Substantially Equivalent Devices CX50 Diagnostic Ultrasound System K091804 / K08 1802 HDi i Diagnostic Ultrasound System K043535 3)Device Description The CX50 Diagnostic… | 2009 |
| * | K081802 | CX50 Diagnostic Ultrasound SystemSummary page 1…Transducer, Ultrasonic, diagnostic 90 ITX 3)Substantially Equivalent Devices CX50 Diagnostic Ultrasound System K091804 / K08 1802 HDi i Diagnostic Ultrasound System K043535 3)Device Description The CX50 Diagnostic Ultrasound… | 2008 |
| * | K043535 | HD11 Diagnostic Ultrasound SystemSummary page 1…antially Equivalent Devices CX50 Diagnostic Ultrasound System K091804 / K08 1802 HDi i Diagnostic Ultrasound System K043535 3)Device Description The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 - channel, car… | 2005 |
What descends from it? (56)
See all 563 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2025 | Class III | Z-2362-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2368-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2352-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2372-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2412-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2366-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| May 28, 2025 | Class II | Z-2066-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2054-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2058-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2049-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K123754 (Philips Ultrasound, Inc., 2012) has gone furthest, with 53 descendants of its own.
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. 2011, 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 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 Neonatal Cephalic…
Read the full statement (99 words)
Philips CX50 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
Neonatal Cephalic
Trans-vaginal
Musculo-skeletal
Gynecological
Cardiac Adult
Cardiac Pediatric
Trans-Esoph. (Cardiac)
Peripheral Vessel
Other (Carotid)
The clinical environments where the CX50 Diagnostic Ultrasound System can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111513: CX50 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/K111513
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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