# K230179: 6440 MyLabX90

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Nov 29, 2023 after 310 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K935595 (1995). 335 ancestors in all.
4 later devices descend from it; 2 cite it directly.
7 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173291: 6440 Ultrasound System, Esaote, S.p.A. (2018) Summary page 5.

## Most influential descendants
- K243253: 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (2025), 2 descendants of its own
- K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (2025), 2 descendants of its own
- K253288: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (2026), 0 descendants of its own
- K253310: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (2025), 0 descendants of its own

## Recalls of this device
- Mar 14, 2025 · Class II · Z-1490-2026: A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

## Indications for use
The multifunctional ultrasound scanner MyLabX90 is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by providing additional image information from a second imaging modality. As second imaging modality it is intended any image coming from CT, MR, US, PET,XA and NM. The second modality provides additional security in assessing the morphology of the real time ultrasound image.

Source page: https://510kreport.com/device/K230179
Methodology: https://510kreport.com/methodology