# K162290: MyLabSix CrystaLine

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Oct 14, 2016 after 60 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: 17 generations back to K935595 (1995). 168 ancestors in all.
No later device cites it as a predicate yet.
1 of 169 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161359: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System, Esaote, S.p.A. (2016) Summary page 6.
- K141486: Mylabsix Ultrasound System, Esaote Europe B.V. (2014) Summary page 30.

## Indications for use
Esaote’s Model 6425 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/K162290
Methodology: https://510kreport.com/methodology