510(k) · Cleared
Recalled · Class II · 2025CX50 Version 2.0 Diagnostic Ultrasound System and Transducers
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 17, 2009 as substantially equivalent to K030455 (Philips Ultrasound, Inc., 2003) after a 29-day review. Its family tree reaches back 2 generations to 1997. 57 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 17, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961459 (1997). 4 ancestors in all. 57 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
- 1 generation backK030455 Boris Platform Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2003 · Recalled
- This deviceK091804 CX50 Version 2.0 Diagnostic Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2009
- 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 |
|---|---|---|---|---|---|
| −2 | K961459 | Level 10 Hdi | Advanced Technology Laboratories, Inc. | 1997 | — |
| −1 | K030455 | Boris Platform Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2003 | 31 |
| 0 (this device) | K091804 | CX50 Version 2.0 Diagnostic Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2009 | — |
| +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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K030455 | Boris Platform Diagnostic Ultrasound SystemSummary page 1…the CX50 system. These expanded intended uses are all within the cleared intended uses for the predicate device, Philips iU22 diagnostic ultrasound s yste leared in K030455), to which CX50 2.0 is subst~antqil y eq et CX50 2.0 is intended for diagnostic ultrasound imaging and fluid flow analysis.… | 2003 |
| † | K041949 | Allura Xper FD10 | 2004 |
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-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. |
| 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 7 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 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K111513 (Philips Ultrasound, Inc., 2011) has gone furthest, with 56 descendants of its own.
- 5 other devices also cite its predicate K030455.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The CX50 2.0 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 clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal…
Read the full statement (94 words)
The CX50 2.0 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 clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological.
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/K091804 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091804: CX50 Version 2.0 Diagnostic Ultrasound System and Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091804
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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