# K213642: Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jan 13, 2022 after 56 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). 133 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180374: Voluson S8/ Voluson S10/ Voluson S10 Expert, GE Healthcare (2018) Summary page 4.

## Most influential descendants
- K233692: Voluson Signature 20, Voluson Signature 18 (2024), 0 descendants of its own

## Indications for use
Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson S6 / Voluson S8 / Voluson S8t/ Voluson S10 / Voluson S10 Expert 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, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S8t/ Voluson S10 / Voluson S10 Expert are intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K213642
Methodology: https://510kreport.com/methodology