# K091804: CX50 Version 2.0 Diagnostic Ultrasound System and Transducers

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jul 17, 2009 after 29 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961459 (1997). 4 ancestors in all.
57 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030455: Boris Platform Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2003) Summary page 1.

## Most influential descendants
- K111513: CX50 Diagnostic Ultrasound System (2011), 56 descendants of its own
- K123754: CX50 3.0 Diagnostic Ultrasound System (2012), 53 descendants of its own
- K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System (2016), 27 descendants of its own
- K142710: S9 Portable Digital Color Doppler Ultrasound System (2015), 19 descendants of its own
- K201012: EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (2020), 18 descendants of its own

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2362-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2368-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2352-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2372-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 28, 2025 · Class II · Z-2054-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- May 28, 2025 · Class II · Z-2058-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- May 28, 2025 · Class II · Z-2049-2025: Ultrasound transducer devices were refurbished beyond their useful life.

## Indications for use
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.

Source page: https://510kreport.com/device/K091804
Methodology: https://510kreport.com/methodology