# K213689: Voluson P6, Voluson P8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Feb 17, 2022 after 86 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). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180535: Voluson P6 and Voluson P8, GE Healthcare (2018) Summary page 4.

## Indications for use
Voluson P6 / Voluson P8 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 P6 / Voluson P8 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, HD-Flow, Harmonic Imaging, 3D/4D Imaging mode, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson P6 / Voluson P8 are intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K213689
Methodology: https://510kreport.com/methodology