# K160162: Voluson P6, Voluson P8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 26, 2016 after 90 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: 20 generations back to K935595 (1995). 124 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141675: Voluson P6, Voluson P8, GE Healthcare (2014) Summary page 12.
- K152567: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System, GE Healthcare (2015) Summary page 12.
- K142472: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems, GE Healthcare (2015) Summary page 12.

## Most influential descendants
- K180535: Voluson P6 and Voluson P8 (2018), 12 descendants of its own
- K201828: Voluson SWIFT, Voluson SWIFT+ (2020), 10 descendants of its own
- 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

## 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 (Including Urology and Prostate) (TR); Transvaginal (TV).

Source page: https://510kreport.com/device/K160162
Methodology: https://510kreport.com/methodology