510(k) · Cleared
Recalled · Class II · 2025CX50 3.0 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 Dec 21, 2012 as substantially equivalent to K111513 (Philips Ultrasound, Inc., 2011) and 2 other predicates after a 15-day review. Its family tree reaches back 6 generations to 2000. 53 later devices descend from it. It has been recalled 22 times.
- Decided
- Dec 21, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 22
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000695 (2000). 14 ancestors in all, the oldest K961459 (1997). 53 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 5 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 4 generations backK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
- 3 generations backK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
- 2 generations backK081802 CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2008 · Recalled
- 1 generation backK111513 CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2011 · Recalled
- This deviceK123754 CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2012
- Descendant · cites it directly · 27 of its ownK162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · Recalled
- Descendant · cites it directly · 19 of its ownK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
- Descendant · 2 generations on · 18 of its ownK201012 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic…Philips Ultrasound, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 17 of its ownK211597 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic…Philips Medical Systems · 2021
- Descendant · 2 generations on · 17 of its ownK150045 S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · cites it directly27descendants
- K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015 · cites it directly19descendants
- K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc. · 2020 · 2 generations on18descendants
- K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems · 2021 · 3 generations on17descendants
- K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −5 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −4 | K033139 | GE Marlin Ultrasound | General Electric Co. | 2003 | 1 |
| −3 | K061525 | GE Vivid - I | General Electric Co. | 2006 | 1 |
| −2 | K081802 | CX50 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2008 | 4 |
| −1 | K111513 | CX50 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2011 | 10 |
| 0 (this device) | K123754 | CX50 3.0 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2012 | — |
| +1 | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | Philips Health Care | 2016 | 3 |
| +1 | K142710 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015 | — |
| +2 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound… | Philips Ultrasound, Inc. | 2020 | 5 |
| +3 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic… | Philips Medical Systems | 2021 | — |
| +2 | K150045 | S30/S40 Digital Color Doppler Ultraound System | Sonoscape Company Limited | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111513 | CX50 Diagnostic Ultrasound SystemSummary page 7…9. Infertility monitoring of follicle development Combined modes: B+PWD, B±Color, B+M, B+M+Color, B±Color+PWO, B+CWD, B+Color±CWD Previous submission: KI 111513 for CX5O (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiolog… | 2011 |
| * | K062247 | HD11 Diagnostic Ultrasound SystemSummary page 1…Philips Healthcare CX50 Diagnostic Ultrasound System KI 11513 Philips Healthcare HDI I Diagnostic Ultrasound System K062247 Philips iU22 (formerly known as Boris) K03045S 3) Device Description The CX50 Di… | 2006 |
| * | K030455 | Boris Platform Diagnostic Ultrasound SystemSummary page 2…o The lntraoperative indication employs the L15-7io and the C9-3io. The LlS-7io was cleared for use with the Philips iU22 (formerly known as Boris, K030455). The C9-3io is similar to the LI 5-7io, but curved rather than linear. o The laparoscopic indication em… | 2003 |
What descends from it? (53)
See all 533 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 |
|---|---|---|---|---|
| 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-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-2389-2025 | 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-2377-2025 | 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-2401-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-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-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-2378-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2350-2025 | 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. |
| 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. |
| Jul 3, 2025 | Class III | Z-2397-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2359-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2369-2025 | 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 22 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 12 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 14 ancestors have a recall of any class.
- Of its descendants, K162329 (Philips Health Care, 2016) has gone furthest, with 27 descendants of its own.
- 2 other devices also cite its predicate K111513.
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. 2012, 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 Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult…
Read the full statement (103 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
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)
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/K123754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123754: CX50 3.0 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/K123754
Report an extraction error
Are you the manufacturer?
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