# K180374: Voluson S8/ Voluson S10/ Voluson S10 Expert

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Mar 13, 2018 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: 21 generations back to K935595 (1995). 132 ancestors in all.
2 later devices descend 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)
- K160184: Voluson S6, Voluson S8, Voluson S10, GE Healthcare (2016) Summary page 4.

## Most influential descendants
- K213642: Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (2022), 1 descendant of its own
- K233692: Voluson Signature 20, Voluson Signature 18 (2024), 0 descendants of its own

## Recalls of this device
- Jul 2, 2019 · Class II · Z-1965-2019: Potential for a transducer mis-alignment in certain transvaginal probes.

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

Source page: https://510kreport.com/device/K180374
Methodology: https://510kreport.com/methodology