# K201828: Voluson SWIFT, Voluson SWIFT+

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Oct 11, 2020 after 101 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: 22 generations back to K935595 (1995). 126 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180535: Voluson P6 and Voluson P8, GE Healthcare (2018) Summary page 4.

## Most influential descendants
- K230365: Sonio Detect (2023), 7 descendants of its own
- K240406: Sonio Detect (2024), 4 descendants of its own
- K241380: Fetoly-Heart (2024), 1 descendant of its own
- K230346: Voluson SWIFT; Voluson SWIFT+ (2023), 1 descendant of its own
- K252433: Sonio Detect  (v3) (2026), 0 descendants of its own

## Indications for use
The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/Prostate) (TR); Transvaginal (TV). Mode 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 and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K201828
Methodology: https://510kreport.com/methodology