# K141486: Mylabsix Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote Europe B.V.
- Decided: Jul 11, 2014 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: 14 generations back to K935595 (1995). 158 ancestors in all.
8 later devices descend from it; 4 cite it directly.
1 of 167 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111302: Mylabseven, Mylabalpha, Esaote, S.p.A. (2011) Summary page 2.
- K132231: Mylabseven, Mylabalpha, Esaote, S.p.A. (2013) Summary page 3.
- K132466: Mylabseven 6400, Mylabalpha 7400, Esaote, S.p.A. (2013) Summary page 3.
- K083882: Mylabfive, Esaote Europe B.V. (2009) Summary page 2.

## Most influential descendants
- K142077: Mylabgamma (2014), 5 descendants of its own
- K161359: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System (2016), 4 descendants of its own
- K161168: MyLabSix Ultrasound System (2016), 1 descendant of its own
- K191072: 7410 Ultrasound System (MyLabSigma) (2019), 0 descendants of its own
- K190989: 6400 Ultrasound System (MyLabX6, MyLabX7) (2019), 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, 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/K141486
Methodology: https://510kreport.com/methodology