# K081802: CX50 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jul 11, 2008 after 15 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000695 (2000). 5 ancestors in all.
57 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043535: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2005) Summary page 1.
- K061525: GE Vivid - I, General Electric Co. (2006) 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-2412-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2366-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 28, 2025 · Class II · Z-2066-2025: 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.

## Indications for use
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:

Source page: https://510kreport.com/device/K081802
Methodology: https://510kreport.com/methodology