# K183191: 6420 Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: Dec 4, 2018 after 15 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: 21 generations back to K935595 (1995). 338 ancestors in all.
No later device cites it as a predicate yet.
7 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161168: MyLabSix Ultrasound System, Esaote Europe B.V. (2016) Summary page 33.
- K173291: 6440 Ultrasound System, Esaote, S.p.A. (2018) Summary page 33.
- K141486: Mylabsix Ultrasound System, Esaote Europe B.V. (2014) Summary page 34.

## Indications for use
Esaote's 6420 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

Source page: https://510kreport.com/device/K183191
Methodology: https://510kreport.com/methodology