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. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 11, 2008 as substantially equivalent to K043535 (Philips Ultrasound, Inc., 2005) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 2000. 57 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 11, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000695 (2000). 5 ancestors in all. 57 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 3 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 2 generations backK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
- 1 generation backK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
- This deviceK081802 CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2008
- Descendant · cites it directly · 56 of its ownK111513 CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 53 of its ownK123754 CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 27 of its ownK162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · Recalled
- Descendant · 3 generations on · 19 of its ownK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
- Descendant · 4 generations on · 18 of its ownK201012 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic…Philips Ultrasound, Inc. · 2020 · Recalled
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K111513CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2011 · cites it directly56descendants
- K123754CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2012 · 2 generations on53descendants
- K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · 3 generations on27descendants
- K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015 · 3 generations on19descendants
- K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc. · 2020 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −3 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −2 | K033139 | GE Marlin Ultrasound | General Electric Co. | 2003 | 1 |
| −1 | K061525 | GE Vivid - I | General Electric Co. | 2006 | 1 |
| 0 (this device) | K081802 | CX50 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2008 | — |
| +1 | K111513 | CX50 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2011 | 10 |
| +2 | K123754 | CX50 3.0 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2012 | 22 |
| +3 | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | Philips Health Care | 2016 | 3 |
| +3 | K142710 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015 | — |
| +4 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound… | Philips Ultrasound, Inc. | 2020 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K043535 | HD11 Diagnostic Ultrasound SystemSummary page 1…screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed Philips HD1 I ultrasound system and transducers cleared in K043535 and the General Electric Vivid-i ultrasound system and transducers cleared in K061525.… | 2005 |
| * | K061525 | GE Vivid - ISummary page 1…o the currently marketed Philips HD1 I ultrasound system and transducers cleared in K043535 and the General Electric Vivid-i ultrasound system and transducers cleared in K061525. Page 9 510(k) Premarket Notification… | 2006 |
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111513 | CX50 Diagnostic Ultrasound System | 2011 | 56 |
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-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-2058-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K111513 (Philips Ultrasound, Inc., 2011) has gone furthest, with 56 descendants of its own.
- 3 other devices also cite its predicate K043535.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
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:
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/K081802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081802: 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/K081802
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