# K161168: MyLabSix Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote Europe B.V.
- Decided: Sep 2, 2016 after 129 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: 15 generations back to K935595 (1995). 161 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 163 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141486: Mylabsix Ultrasound System, Esaote Europe B.V. (2014) Summary page 4.
- K111302: Mylabseven, Mylabalpha, Esaote, S.p.A. (2011) Summary page 33.
- K132231: Mylabseven, Mylabalpha, Esaote, S.p.A. (2013) Summary page 33.
- K132466: Mylabseven 6400, Mylabalpha 7400, Esaote, S.p.A. (2013) Summary page 33.
- K142008: Mylabseven, Mylabalpha, Esaote, S.p.A. (2014) Summary page 32.
- K101605: Mylabone Ultrasound System, Esaote Europe B.V. (2010) Summary page 7.
- K113156: Sonosite Edge Ultrasound System, Sonosite,Inc. (2011) Summary page 32.

## Most influential descendants
- K183191: 6420 Ultrasound System (2018), 0 descendants of its own

## Indications for use
Esaote’s MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Source page: https://510kreport.com/device/K161168
Methodology: https://510kreport.com/methodology