# K122387: Voluson P6, Voluson P8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 11, 2012 after 36 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: 16 generations back to K935595 (1995). 116 ancestors in all.
201 later devices descend from it; 4 cite it directly.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120741: Voluson S6, Voluson S8, GE Healthcare (2012) Summary page 1.
- K113758: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012)

## Most influential descendants
- K133034: Logiq F Series (2014), 155 descendants of its own
- K141639: Voluson S6, Voluson S8 (2014), 151 descendants of its own
- K143452: Logiq P9, Logiq P7 (2015), 131 descendants of its own
- K161047: LOGIQ P9 and LOGIQ P7 (2016), 107 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants 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/K122387
Methodology: https://510kreport.com/methodology