# K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: May 16, 2025 after 339 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). 337 ancestors in all.
2 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)
- K192157: 6450 Ultrasound system, Esaote, S.p.A. (2019) Summary page 6.
- K230179: 6440 MyLabX90, Esaote, S.p.A. (2023) Summary page 6.

## Most influential descendants
- 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

## Indications for use
The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main application: Districts: Invasive access: Cardiac Cardiac Adult, Cardiac Pediatric Transesophageal Vascular Neonatal, Adult Cephalic, Vascular Not applicable General Imaging Abdominal, Breast, Musculoskeletal, Intraoperative (Abdominal), Neonatal, Pediatric, Small Organs Laparoscopic, Transrectal (Testicles), Thyroid, Urological Women Health OB/Fetal, Gynecology Transrectal, Transvaginal 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. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI. The ultrasound scanner is suitable to be installed in professional healthcare facility environment and is designed for ultrasound practitioners.

Source page: https://510kreport.com/device/K241671
Methodology: https://510kreport.com/methodology