# K180535: Voluson P6 and Voluson P8

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Mar 29, 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). 125 ancestors in all.
12 later devices descend from it; 2 cite 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)
- K160162: Voluson P6, Voluson P8, GE Healthcare (2016) Summary page 4.

## Most influential descendants
- 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
- K230346: Voluson SWIFT; Voluson SWIFT+ (2023), 1 descendant 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
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K180535
Methodology: https://510kreport.com/methodology