# K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Sep 14, 2016 after 26 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 137 ancestors in all.
27 later devices descend from it; 6 cite it directly.
6 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123754: CX50 3.0 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2012) Summary page 5.
- K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2016) Summary page 19.

## Most influential descendants
- 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
- K211597: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (2021), 17 descendants of its own
- K233788: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (2024), 16 descendants of its own
- K240850: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (2024), 14 descendants of its own
- K243794: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (2025), 5 descendants of its own

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2370-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2361-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Aug 30, 2019 · Class II · Z-1841-2020: The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure t

## Indications for use
Philips CX50 Diagnostic Ultrasound Systems 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) Philips Sparq 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 Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel

Source page: https://510kreport.com/device/K162329
Methodology: https://510kreport.com/methodology