# K251169: Vivid Pioneer

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jul 10, 2025 after 86 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K935595 (1995). 224 ancestors in all.
No later device cites it as a predicate yet.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220882: Vivid E80, Vivid E90, Vivid E95, Ge Medical Systems Ultrasound And (2022) Summary page 5.

## Indications for use
Vivid Pioneer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid Pioneer is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, lntra-luminal and lnterventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural and lntraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Source page: https://510kreport.com/device/K251169
Methodology: https://510kreport.com/methodology