# K212021: 6430 MyLabX75, 6430 MyLab XPro75

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Sep 16, 2021 after 80 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: 22 generations back to K935595 (1995). 336 ancestors in all.
No later device cites it as a predicate yet.
7 of 337 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192157: 6450 Ultrasound system, Esaote, S.p.A. (2019) Summary page 5.

## Indications for use
The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes -Cardiac [Adult and Pediatric] -Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic,Transrectal. -Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)] 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 phased array) and Doppler probes. The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.

Source page: https://510kreport.com/device/K212021
Methodology: https://510kreport.com/methodology