# K252328: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Nov 24, 2025 after 122 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: 28 generations back to K935595 (1995). 239 ancestors in all.
No later device cites it as a predicate yet.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242168: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22, GE Medical Systems Ultrasound and Primary Care Diagnostics (2024) Summary page 5.

## Indications for use
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson TM Expert 18, Voluson TM Expert 20, Voluson TM Expert 22 is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K252328
Methodology: https://510kreport.com/methodology