# K160184: Voluson S6, Voluson S8, Voluson S10

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Feb 25, 2016 after 29 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 131 ancestors in all.
55 later devices descend from it; 3 cite it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141639: Voluson S6, Voluson S8, GE Healthcare (2014) Summary page 18.
- K152567: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System, GE Healthcare (2015) Summary page 18.
- K142472: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems, GE Healthcare (2015) Summary page 18.

## Most influential descendants
- K161706: Vivid iq (2016), 46 descendants of its own
- K180599: Venue (2018), 28 descendants of its own
- K183362: Venue GO (2019), 14 descendants of its own
- K170878: Vivid S60N, Vivid S70N (2017), 10 descendants of its own
- K181727: Vivid iq (2018), 9 descendants of its own

## Recalls of this device
- Dec 22, 2023 · Class II · Z-0865-2024: GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features.

## Indications for use
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics): Abdominal (including renal and GYN/pelvic): Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV): Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Source page: https://510kreport.com/device/K160184
Methodology: https://510kreport.com/methodology